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  • Botulism outbreak sickens more than 50 babies and expands to all ByHeart products

    Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.No deaths have been reported in the outbreak, which was announced Nov. 8.Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. Another 12 cases were identified with the expanded definition, including two that occurred in the original timeline and 10 that occurred from December 2023 through July 2025.ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo, 36, of Redondo Beach, California, said she insisted on using ByHeart formula to supplement a low supply of breast milk because it was recommended by a lactation consultant as “very natural, very gentle, very good for the babies.”“That’s a hard one,” Galindo said. “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old son, Hank, fell ill and was treated for botulism in March, weeks after he began drinking ByHeart. Being included in the investigation of the outbreak “feels like a win for all of us,” she said Wednesday.“I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears — a mix of relief, gratitude and hope that the truth is finally being recognized,” she said.In a statement late Wednesday, ByHeart officials said the company is cooperating with federal officials “to understand the full scope of related cases.”“The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination,” the statement said.Lab tests detected contaminationThe FDA sent inspectors last month to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.The company previously reported that tests by an independent laboratory showed that 36 samples from three different lots contained the type of bacteria that can cause infant botulism.“We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company wrote on its website last month.Those results and discussions with the FDA led CDC officials to expand the outbreak, according to Dr. Jennifer Cope, a CDC scientist leading the investigation.“It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots,” Cope said. “They couldn’t isolate it to specific lots from a certain time period.”Inspection documents showed that ByHeart had a history of problems with contamination.In 2022, the year ByHeart started making formula, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for a different germ, cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just before FDA inspectors found problems with mold, water leaks and insects, documents show.Infant botulism is rareInfant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It’s caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin.Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, according to research studies.Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s infant botulism program developed the product and is the sole source worldwide.The antibodies provided by BabyBIG are likely most effective for about a month, although they may continue circulating in the child’s system for several months, said Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital.“The risk to the infant is ongoing and the family should not be using this formula after it was recalled,” Nachman said in an email.Families of several babies treated for botulism after drinking ByHeart formula have sued the company. Lawsuits filed in federal courts allege that the formula they fed their children was defective and ByHeart was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

    Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.

    The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.

    The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.

    No deaths have been reported in the outbreak, which was announced Nov. 8.

    Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. Another 12 cases were identified with the expanded definition, including two that occurred in the original timeline and 10 that occurred from December 2023 through July 2025.

    ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.

    News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo, 36, of Redondo Beach, California, said she insisted on using ByHeart formula to supplement a low supply of breast milk because it was recommended by a lactation consultant as “very natural, very gentle, very good for the babies.”

    “That’s a hard one,” Galindo said. “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”

    Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old son, Hank, fell ill and was treated for botulism in March, weeks after he began drinking ByHeart. Being included in the investigation of the outbreak “feels like a win for all of us,” she said Wednesday.

    “I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears — a mix of relief, gratitude and hope that the truth is finally being recognized,” she said.

    In a statement late Wednesday, ByHeart officials said the company is cooperating with federal officials “to understand the full scope of related cases.”

    “The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination,” the statement said.

    Lab tests detected contamination

    The FDA sent inspectors last month to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.

    The company previously reported that tests by an independent laboratory showed that 36 samples from three different lots contained the type of bacteria that can cause infant botulism.

    “We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company wrote on its website last month.

    Those results and discussions with the FDA led CDC officials to expand the outbreak, according to Dr. Jennifer Cope, a CDC scientist leading the investigation.

    “It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots,” Cope said. “They couldn’t isolate it to specific lots from a certain time period.”

    Inspection documents showed that ByHeart had a history of problems with contamination.

    In 2022, the year ByHeart started making formula, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for a different germ, cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”

    A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just before FDA inspectors found problems with mold, water leaks and insects, documents show.

    Infant botulism is rare

    Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It’s caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin.

    Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, according to research studies.

    Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.

    The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s infant botulism program developed the product and is the sole source worldwide.

    The antibodies provided by BabyBIG are likely most effective for about a month, although they may continue circulating in the child’s system for several months, said Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital.

    “The risk to the infant is ongoing and the family should not be using this formula after it was recalled,” Nachman said in an email.

    Families of several babies treated for botulism after drinking ByHeart formula have sued the company. Lawsuits filed in federal courts allege that the formula they fed their children was defective and ByHeart was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

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  • Looking to winterize your skin? DC dermatologist on how lotions ‘will not cut it’ this time of year – WTOP News

    A D.C. dermatologist has tips on how to help your skin combat the cold, dry air of winter and avoid flare-ups of conditions like eczema.

    WTOP’s Alan Etter on how to winterize your skin in dry weather.

    The cold, dry air of winter can make your skin drier than usual and make skin conditions like eczema harder to keep under control.

    But there are strategies to help winterize your skin and combat the weather changes.

    Dr. Adam Friedman, professor and chair of dermatology at George Washington University School Medicine and Health Sciences, said there are certain things you can be doing to keep your skin hydrated.

    “Your moisturizer needs a winter upgrade,” Friedman said. “Lotions will not cut it this time of year. I recommend creams and ointments to actually trap and hold moisture in the skin, giving the skin a time to repair and actually stay calm.”

    So what should you be looking for on the bottles and tubes?

    “Products that say ‘for eczema,’ as this is an FDA regulated term requiring a barrier protectant called colloidal oatmeal, which has decades of supporting data,” he said.

    And if your skin is really thick and flakey, he said to look for exfoliating products.

    “Keratolytics like urea, mandelic acid … ammonium lactate, these can safely exfoliate that thick skin and help pull water in,” he said.

    He said the simpler the better, when it comes to what is in the products. You want to limit how often you’re cleansing and avoid lengthy showers.

    “We want mild cleansers, because bathing, how one bathes, can play a very big role in how dry one’s skin is during the wintertime,” he said. “We want to keep showers short, not scalding hot, lukewarm. The most important thing is using a mild cleanser, and honestly, not to the whole body.”

    He said not every body part needs to be cleaned everyday. So what should you be doing?

    “The only areas that need soap every day are the underarms, face and groin,” Friedman said. “We can skip a day here and there, because soap is very drying. But then even more importantly is applying that cream or ointment based moisturizer to damp skin, usually within 30 seconds after getting out of the shower.”

    And when it comes to which brands to buy?

    “If a claim sounds too good to be true, it probably is,” he said. “My advice is, go for the bigger name brands that have the resources and take the time to actually evaluate their products with clinical studies.”

    WTOP’s Mike Murillo contributed to this report. 

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    © 2025 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

    Valerie Bonk

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  • FDA warns consumers about 19 cookware products that could leach lead into your food. Here’s the list.

    The Food and Drug Administration is warning consumers about 19 types of cookware that may contain lead, increasing the risk that the toxic metal could wind up in people’s food. 

    Consumers should check whether they have the items in their homes, and throw them away if they do, the FDA said in an alert posted on its website. 

    “Do not donate or refurbish this cookware,” the agency noted.  

    The suspect cookware, all manufactured outside the U.S. and mostly in India, is made from aluminum, aluminum alloys and brass that have been tested by the FDA and state agencies, with the results showing that they can leach lead into food.

    The FDA’s warning expands on its August alert about the cookware, with the agency adding nine products to its list of items to discard due to the risk of lead exposure. 

    Lead poisoning can lead to symptoms including abdominal pain, nausea, vomiting, appetite loss, memory loss, and pain or tingling in your hands or feet, among other issues, according to the Centers for Disease Control and Prevention. Children are especially sensitive to lead, which can damage their brains and nervous systems, slowing their growth and development, the agency says.

    Women of childbearing age and new mothers who are breastfeeding their infants are also at risk for lead poisoning, the FDA notes.

    Below are the cookware products the FDA says should be discarded, along with the manufacturer or distributor when that is specified. The items were sold by a handful of retailers in states including California, Illinois, Maryland, New Jersey and New York, as well as Washington, D.C. The FDA didn’t specify if the products were sold more widely, but noted that other items could be added to its alert.

    • Sonex aluminum pot (Manufacturer: Sonex Cookware)
    • IKM aluminum saucepan, size 2 with a 9″ wooden handle (Manufacturer: JSM Foods)
    • IKM 4-quarter pital brass pot (Manufacturer: JSM Foods)
    • Brass tope (Manufacturer: Kraftwares)
    • Aluminum kadai size 5 (Distributor: Lotus Mom)
    • Silver Horse aluminum caldero 28
    • Silver Horse aluminum degda 24
    • Silver Horse aluminum degda 20
    • Silver Horse kadai 26
    • Silver Horse aluminum milk pan 4
    • Chef Milk pan, 24 centimeters (Distributor: Shata Traders)
    • Aluminum hammered kadai, size 7 (Distributor: Indian Cookware & Appliance 
    • Brass pot (sold at Santos Agency)
    • Dolphin brand aluminum saucepan
    • 2-quart aluminum saucepan (Distributor: Win Chong Trading Corp.)
    • 3-quart aluminum saucepan (Distributor: Win Chong Trading Corp.)
    • Royal Kitchen cookware, milk pan size 3 (Distributor: New Reliance Traders)
    • Tiger White kadai 
    • JK Vallabhdas aluminum kadai (Grain Market)

    A kadai is a type of wide pan used in South Asian cooking, while a degda is a type of pot often used to cook rice. A tope is another type of pot used in South Asian cooking.

    The FDA urged retailers and distributors to contact the agency with any questions about the safety and regulatory status of any products they sell that are used to prepare food. Contact the FDA at premarkt@fda.hhs.gov.

    Edited by

    Alain Sherter

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  • Boar’s Head Cheese Recall Over Potential Listeria Contamination – KXL

    WASHINGTON, DC – Boar’s Head cheese products are being recalled over potential Listeria contamination. According to the FDA, a Boar’s Head supplier issued the recall and it’s being categorized as a Class One, which means exposure could result in serious health consequences or death.

    The recalled items included Boar’s Head Grated Pecorino Romano Cheese, FS Grated Romano Cheese, Pre-cut Pecorino Romano, EverRoast Chicken Caesar Salad, and EverRoast Chicken Caesar Wraps sold at Kroger stores in Kentucky and Indiana.

    According to the recall alert, the affected products are past their shelf life and “should already be out of distribution,” however, consumers are advised to discard any remaining products that may be in their possession.

    More about:

    Tim Lantz

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  • Dessert recall map shows new warning issued in 33 states

    Prime Food Processing LLC is voluntarily recalling over 2,000 cases of two dessert buns due to the packaging not declaring milk, affecting nearly three dozen states.

    Newsweek reached out to the company via phone on Friday night after hours and left a message.

    Why It Matters

    Numerous public health alerts and recalls have been issued this year due to potential damage, foodborne illness, contamination and undeclared food allergens.

    Millions of Americans experience food sensitivities or allergies every year. According to the U.S. Food and Drug Administration (FDA), the nine “major” food allergens in the United States are eggs, milk, fish, wheat, soybeans, crustacean shellfish, sesame, tree nuts and peanuts.

    “People who have an allergy or severe sensitivity to milk risk a serious or life-threatening allergic reaction if they consume these products,” the alert warns in part.

    What To Know

    According to the alert, the voluntary recall includes 2,243 cases of the dessert buns. The products were distributed to Asian grocery stores from April 2, 2025, to November 14, 2025.

    Prime Food brand Lava Bun with Salted Egg Yolk with UPC number 97903705873- 24 oz. Item #PD4188 is impacted by the recall, with a lot code range of 25092-25318 and an expiration range of 07/26-03/27, the alert notes.

    Prime Food brand Lava Bun with Green Tea Flavor is also included in the recall, with UPC number #97803705883- 24 oz. Item #PD4198. The product has a lot code range of 25092-25318 and an expiration range of 07/26-03/27, according to the alert.

    “The milk in these products is derived from unsalted butter listed in the ingredient statement,” the alert says in part.

    There have been no allergic reactions or illnesses reported as of Thursday, the alert notes. The impacted 33 states are as follows: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.

    Below is a map of the impacted states:

    What People Are Saying

    The alert, in part: “The issue was identified during an internal product review. The recall was initiated after it was discovered that packaging did not declare milk in the allergen statement. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s label review process.”

    What Happens Next

    Customers who have purchased the recalled dessert buns are urged to return the uneaten product and packaging for a full refund, the alert says.

    People with additional questions may contact the company via phone at 718-963-2323 from 9 a.m. to 5 p.m. ET weekdays.

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  • Patient guide to menopause HRT, must-knows after FDA change

    What does it mean when a warning label is removed from a medication after two decades?

    On Nov. 10, the U.S. Food and Drug Administration said it will ask companies to remove most “black box” safety warnings — used on medications to warn patients of serious health risks —  from hormone drugs commonly used to treat menopause symptoms. The change comes after years of advocacy from gynecologists, patients and professional medical organizations. 

    The FDA began requiring the warnings in 2003 after results from a large study raised concerns the medications could increase the risk of breast cancer, stroke and heart attack. Patients became hesitant to take the medications, and prescriptions decreased.

    But the science wasn’t so clear cut. The study that drove the change included mostly women older than 60, and hormone formulations and delivery methods different from what’s often used today. More recent scientific research has shown the medications to be much safer than previously believed, especially for women under 60. Some types of hormone therapy slightly increase a woman’s risk for certain health conditions, but the increased risk is small. 

    We spoke with four OB/GYNs who specialize in menopause management to find out what you need to know before your next doctor’s appointment. 

    What are the types of menopause hormone therapies? 

    Menopause hormone therapy, sometimes called hormone replacement therapy or HRT, refers to medications prescribed to treat menopause symptoms, including hot flashes, night sweats, mood swings and vaginal dryness. They work by replenishing hormones, such as estrogen and progesterone, that naturally diminish during the transition to menopause. 

    The medications take several forms. 

    Local estrogen therapy comes in creams, rings and tablets. These treatments are called “local” because their impact is limited to the area where they are applied, such as the vagina. These therapies address symptoms including vaginal dryness, itching, urinary tract infections and the sudden urge to urinate.

    With local therapies, the hormones are absorbed into the bloodstream only in trace amounts, making them a low-risk option. However, it also means they can’t treat broader symptoms, such as hot flashes or mood swings.

    Systemic hormone therapy, on the other hand, is designed to circulate the hormones throughout the bloodstream. It offers whole-body benefits but also carries more risk as a result. These therapies are administered orally or absorbed through the skin via patches, sprays or gels.  

    Systemic therapies include estrogen-only therapy, progesterone-only therapy or a combination of estrogen and progesterone. Women who have had their uterus removed only need to take estrogen. Women who still have their uterus must also take progesterone, often in combination with estrogen, to  protect against endometrial cancer. The FDA said black-box warnings for endometrial cancer will remain on estrogen-only systemic medications. 

    Different versions of estrogen and progesterone carry different risks and benefits. 

    “The treatments are highly individualized,” Dr. Marcy Nagpal, an OB/GYN at the Medical University of South Carolina, said in an email to PolitiFact. Talking with your doctor is the best way to know which therapy might be right for you. 

    Which patients are the best candidates for these meds? 

    Women with menopausal symptoms who are under 60, or women who had their last menstrual period within the last 10 years, doctors told us.

    But others can be candidates, too. 

    “At this time, it’s reasonable for anyone who feels that they are experiencing symptoms related to menopause to consider evaluation and treatment options,” Nagpal said. 

    If you don’t have symptoms, you do not need to take menopausal hormone therapy, said Dr. Jennifer Howell, a Duke University OB/GYN. It’s “not generally recommended for health promotion.” 

    Some people might be less suited for systemic therapies. Among them: Women who have or had breast cancer; who suffered a heart attack or stroke; who have had blood clots in their legs, lungs or brain; or who have active liver or gallbladder disease. Alternative medications and non-hormonal options to manage the menopause symptoms also are available, doctors said. 

    What are the benefits? 

    Doctors we talked to overwhelmingly pointed to symptom relief. 

    “Hot flashes and night sweats stop, sleep improves, mood is stabilized, joint pain often improves, and vaginal dryness and pain with vaginal penetration resolves,” said Dr. Karen Adams, OB/GYN and director of the menopause program at Stanford Medicine. She said recurrent urinary tract infections and frequent urination can stop.

    Dr. Nanette Santoro, an OB/GYN and professor at the University of Colorado, said, “Depending on just how annoying and disruptive those symptoms are, (the medications) can be a godsend.”

    While taken, systemic therapy can also prevent the rapid loss of bone density that typically accompanies menopause. 

    “Women can lose up to 20% of bone mass in the first five years after their final period,” said Adams. Stronger bones can reduce the risk of fracture and osteoporosis.

    But contrary to recent claims, data on whether hormone therapy can prevent heart attacks or dementia are not conclusive, Howell and Santoro said. 

    During the FDA announcement about the removal of black box warnings, assertions made about significantly improved cardiovascular health and lower Alzheimer’s risk are not supported by evidence, Adams said. “We absolutely do not have that data.”

    Likewise, the statement that these menopause therapies are life-extending “goes very far beyond the data and is in exactly no clinical guidelines,” Santoro said. 

    What are the risks of menopause hormone therapy? 

    With few exceptions, most symptomatic women can use local low-dose estrogen without risk, Howell said. 

    “The local forms should never have had this labeling at all,” Adams said. “The black box was placed on all estrogen products without regard to whether they were local or systemic, and a correction of that was long overdue.” 

    Systemic hormone therapies carry more risk and can be navigated with a more in-depth conversation with a doctor.

    Research shows that women who take a combination of estrogen and progesterone have an increased risk of breast cancer, but it’s “very small,” Howell said, and mainly pertains to prolonged use among older women.

    “This risk increases slowly and incrementally over time,” Santoro said, and applies to those who take hormones for longer periods, usually more than four to five years. 

    The risk profile also depends on the type of hormones a patient takes. Newer formulas appear to be more neutral for breast cancer risk than the formulas used in the 2002 study that led to the warnings, Adams said. And some estrogen-only therapies have been found to reduce breast cancer risk. 

    With some hormones, the risk varies depending on how they are taken. For example, some oral medications increase the risk for developing blood clots, but when the same medication is absorbed through the skin, it doesn’t appear to have that risk. 

    “Sorting out the risks and benefits for hormone therapy is a task for a patient and her doctor,” Santoro said, to determine the best type of hormones, how long to take them, and how to manage any risks. 

    Will this change impact insurance coverage?

    Doctors said it’s unlikely. 

    Most generic hormone therapy treatments are covered by insurance, Howell said, but specialized formulations that can be more convenient, safe or less messy can be challenging to get covered.  

    Tips for discussing HRT with your doctor

    If you are approaching menopause, or already in the throes of it, here are some pointers about discussing hormone therapy with your doctor. 

    First, make sure you and your doctor are compatible. 

    “This is a topic that can require a deep well of knowledge,” Nagpal said. “It’s reasonable to ask your doctor if they are comfortable with menopause medicine and, if not, to recommend someone who is.” 

    The Menopause Society, a nonprofit for healthcare professionals focused on improving menopause care, offers a search function to find certified providers in your area who have passed a test about menopausal management. 

    When scheduling, consider making an appointment specifically to address treatment options, rather than trying to combine the discussion with other concerns, Nagpal said. 

    On the day of your appointment, Santoro recommended bringing a list of your symptoms, ordered by which you would most like addressed. 

    “It’s not always possible to take care of everything with hormones alone, and knowing the bothersomeness is very helpful to me as the doctor, so I make my best recommendation,” she said. 

    Knowing your own health history — current medications, past health events, how long since your last period — and your family health history can also help.

    Nagpal advises keeping an open mind. 

    “Therapies that are appropriate for one person may not be indicated or appropriate for someone else,” she said. Getting the right dose and regimen might take some trial and error, doctors said. So don’t be alarmed if it takes a few visits and changes to get the most appropriate treatment. 
     

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  • New FDA-approved eye drop aims to help adults with age-related vision issues

    There is a new FDA-approved eye drop on the market called Vizz. This once-daily, prescription eye drop is said to help combat presbyopia, otherwise known as age-related blurry vision.

    Drugmaker LENZ Therapeutics touts that with just one drop in each eye, a person’s vision will improve for up to 10 hours, so they won’t have to wear reading glasses.

    Dr. Robert Johnson Jr. has been running Johnson Family Eyecare in Latrobe, Pennsylvania, for 46 years, and he explains that these eye drops basically act like a focus on a camera lens.

    “Vizz and the drug that has come before it, Vuity, have both worked on the same structural function; they cause your iris, or the colored part of your eye, to get smaller and smaller,” Dr. Johnson explained. “As your pupil gets smaller, it becomes apparent that it is like looking through a pinhole, and your depth of focus therefore increases.”

    Vizz is priced at $79 a month for 25 doses and $198 for three months, 75 doses, but prices may vary at different pharmacies. There are some side effects, including eye redness, headaches, and dimmed vision.

    Dr. Johnson cautions that while these new eye drops may help some, they are not a cure-all for presbyopia, but rather, they are just another good tool in the fight against age-related blurry vision.

    “It will work much better for the younger, 40, 50, 55-year-old patients than it will for the 60, 65, 70-year-old patients,” Dr. Johnson said. “Because they have less of a need to focus. By the time you get to be my age, your natural ability to focus is all gone. Therefore, the pupil would have to be made obsessively smaller and smaller. And if that pupil becomes too small, we begin to lose the amount of light that gets into the eye, and now you are going to have a 70-year-old who can read, but who can’t drive when the sun goes down.”

    Dr. Johnson advises those interested to consult their eye care professional to determine if these eye drops may be right for you.

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  • At Least 15 Babies Contract Infant Botulism Tied To Baby Formula – KXL

    Acquired Through MGN Online on 08/09/2024.

    NEW YORK, NY – America’s infant botulism outbreak is growing with multiple states affected, including New York and New Jersey, despite a nationwide recall of a certain baby formula.

    The FDA warned parents on Saturday that 13 babies in ten states had gotten sick and needed to be hospitalized after drinking ByHeart Whole Nutrition Infant Formula. But now the number has grown to 15 babies in 12 states.  The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Pennsylvania, Rhode Island, Texas, Oregon and Washington.

    All the infants are being treated with BabyBIG, a special IV medicine designed to treat botulism.

    The illness can cause serious complications, including trouble breathing and respiratory arrest. ByHeart, which is based in New York City, first issued a voluntary recall of two lots of formula which it’s now expanded to all.

    More about:

    Tim Lantz

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  • FDA warns websites selling fake or unapproved forms of Botox, similar drugs

    U.S. health regulators sent warning letters Wednesday to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth wrinkles.

    The Food and Drug Administration said it was taking action after receiving reports of injuries in connection with the products, including what it said were symptoms of botulism.

    Botox is a diluted, purified form of botulinum, one of the most toxic substances in the world. The ingredient works by temporarily blocking nerve signals and causing muscles to relax. While most famously approved for cosmetic use, Botox is also approved in the U.S. for a number of medical conditions including muscle spasms, eye disorders and migraines.

    The FDA warning letters mostly went to cosmetics websites. In each case, the FDA said the companies were offering unofficial or mislabeled versions of Botox-like drugs that haven’t been approved by the agency. In addition to the original drug, introduced by Allergan in 1989, the FDA has approved several competing versions.

    FDA-approved Botox drugs carry the agency’s most serious warning, a boxed label alerting doctors and patients that the medications can cause serious or life-threatening side effects.

    In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening muscles needed for breathing and swallowing. Signs of botulism include difficulty swallowing or breathing, slurred speech and muscle weakness. Those symptoms can occur several hours after an injection.

    In a press release Wednesday, the FDA said patients should only receive the drugs from health professionals who are licensed and trained to administer them. Patients experiencing signs of botulism should “seek immediate medical care,” the agency noted. 

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  • FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’

    The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

    WASHINGTON —

    The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

    Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

    “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

    The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.

    The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

    Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.

    Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

    Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

    Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

    Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.

    The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.

    In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.

    According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.

    Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.

    Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.

    The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

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  • FDA’s top drug regulator quits as agency officials probe actions

    Washington — The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

    Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

    “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

    The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements” during his time at the FDA.

    The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

    Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and Tidmarsh was involved in his ouster from those leadership positions, according to the lawsuit.

    Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

    Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

    Upheaval at FDA  

    Tidmarsh’s ouster is the latest in a string of leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

    Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.

    The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.

    In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.

    According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.

    Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.

    Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.

    The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

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  • Kennedy Announces New Cost-Saving Drug Plan – KXL

    Health and Human Services Secretary Robert F. Kennedy Jr. in file photo at the White House with President Trump. (AP Photo/Mark Schiefelbein)

    WASHINGTON, DC – The White House is announcing another plan meant to lower the cost of prescription drugs in the U.S.  On Wednesday, Health and Human Services Secretary Robert F. Kennedy, Jr. announced said the Food and Drug Administration will be making it easier for ” biosimilars” to enter U.S. markets, something Europe has been doing for decades. Biosimilars are drugs similar to those that have been proven to work and have already been approved by the FDA.

    “This is a victory for patients, for innovation, and commonsense,” Kennedy told reporters. “In Europe, for example, regulators have approved more than twice as many biosimilars as the United States,” he added.

    Kennedy says he is cutting the red tape, and clinical trials that are necessary before these types of drugs can be sold in the U.S.

     

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    Tim Lantz

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  • A consumer’s guide to products claiming FDA approval

    An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is “FDA certified” or was “produced in an FDA registered facility.”

    Mention of the U.S. Food and Drug Administration — the agency that regulates drugs, biological products, medical devices, food and cosmetics — might give it the veneer of legitimacy. But not all claims about FDA approval, certification or registration are created equal. 

    The FDA warns that some companies advertise products using fake FDA registration certificates. 

    It can be hard to navigate. 

    “Consumers should be aware that many terms and claims may be misleading and have little, if any, relevance regarding the safety or effectiveness of the product,” said Aaron Lottes, a Purdue University engineering professor with medical device regulation expertise.

    Here’s a consumer guide to the FDA’s regulatory terms — and other terms you might encounter that don’t really come from the agency at all. 

    ‘FDA approved’

    It means: The FDA determined the product is safe and effective for its intended use. For drugs, it means the drug’s benefits outweigh its known and potential risks when used for its intended purpose and following its approved labeling.

    The FDA evaluates lab, animal and clinical testing outcomes and other scientific information to assess whether a product is safe and effective and whether it can be made according to federal quality standards. 

    Things the FDA approves include: 

    • Drugs or products meant to treat or prevent disease.

    • Biological products such as gene therapies, therapeutic proteins, vaccines, allergenic products and products made from plasma.

    • High-risk human medical devices, including mechanical heart valves and implantable infusion pumps.

    • Human food additives that are added to food for a specific purpose, such as when xanthan gum is added to a food to add texture. 

    • Color additives used in food, dietary supplements, drugs, cosmetics and some medical devices.

    The FDA generally does not approve cosmetics such as moisturizers, perfumes, makeup, shampoos, toothpastes and deodorants; infant formula; dietary supplements; food labels or nutrition facts; facilities such as doctors’ offices or labs; or tobacco products. It also does not approve compounded drugs, which a pharmacist or doctor might create to meet the needs of patients with allergies. Another example would include the creation of a compounded liquid formulation of a medication commonly available as a pill for someone with a condition that makes swallowing difficult. 

    Some things fall in between. A product might be both a cosmetic and a drug if it has more than one use and one of its uses would contribute to a disease’s diagnosis, cure, mitigation, treatment or prevention. 

    “An antidandruff shampoo is a cosmetic because its intended use is to cleanse the hair, and it is also a drug because its intended use is to treat dandruff,” the FDA said in a statement. 

    Another example would be antiperspirant deodorant or makeup containing sun protection, the statement said. 

    How to verify a company’s claims about FDA approval: Search the FDA’s approved drug database, the cleared and approved medical devices database and the approved animal drugs database. 

    ‘FDA certified’

    It means: The only type of official FDA certification we found applies to a mammography facility that meets strict standards for providing quality mammograms, X-ray pictures of breasts to help with earlier breast cancer detection. 

    Federal law requires mammography facilities be certified as capable of providing quality mammograms by either the FDA or FDA-approved certification agencies in Illinois, Iowa, South Carolina or Texas. A facility must stop providing mammograms if it is not certified.

    The FDA generally does not certify medical devices or facilities that make them.

    Renee Jeria, the imaging manager, shows the working of the mammography screening machine at the Samuel U. Rodgers Health Center on April 25, 2023 in Kansas City, Mo. (AP)

    How to verify if your mammogram facility is certified: Search the FDA’s certified mammography facilities list or, when you’re there, look for a displayed FDA certificate.

    Watch out for: Companies using fake certificates to claim a product or medical device is FDA certified — a practice the FDA said increased during the COVID-19 pandemic. These fake certificates often mimic official government documents and display the FDA logo.

    ‘FDA registered’

    It means: The FDA has registration paperwork on file from the owners of a domestic or foreign food, drug or medical device facility that produces and distributes products sold in the U.S.

    A facility’s registration with the FDA does not mean the agency approved, cleared or authorized it or the products it creates or distributes. The FDA doesn’t approve facilities, but it can inspect them to verify that they comply with relevant good manufacturing practices and other requirements.

    A facility must be registered if it: 

    How to verify if something is FDA-registered: Search the FDA’s database of registered medical device manufacturers and the registered tobacco product facilities.

    PolitiFact Staff Researcher Caryn Baird contributed to this report.

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  • Oregon E. coli Case Linked To Washington Cheese – KXL

    File image of E. coli bacteria. Credit: MGN

    PORTLAND, OR – The Oregon Health Authority reports that an Oregon resident is one of three people who tested positive for E. Coli bacteria after eating unpasteurized aged cheese produced at the Twin Sisters Creamery Farmhouse in Washington state.

    Samples of leftover cheese obtained from the Oregon resident were tested at a laboratory, and those tests confirmed the presence of  the same E. coli pathogen that was found in two Washington state residents who had indirect exposure to cheese from the same company.  All three people experienced symptoms of E.coli infection between September 5th and September 16th. 

    Twin Sisters Peppercorn Cheese. Courtesy FDA.
    Twin Sisters Farmhouse Cheese. Courtesy FDA.
    Twin Sisters Mustard Seed Cheese. Courtesy FDA.
    Twin Sisters Whatcom Blue Cheese. Courtesy FDA.

    All sizes of Whatcom Blue, Farmhouse, Peppercorn and Mustard Seed varieties of aged cheese from Twin Sisters Creamery produced on or after May 27, 2025, are being recalled.

    • #450 Made on 5/27/2025 – Batch Code 250527B Whatcom Blue
    • #452 Made on 6/10/2025 – Batch Code 250610B Whatcom Blue
    • #454 Made on 6/18/2025 – Batch Code 250618B Whatcom Blue
    • #455 Made on 6/24/2025 – Batch Code 250625B Whatcom Blue
    • #451 Made on 6/03/2025 – Batch Code 250603F Farmhouse
    • #453 Made on 6/16/2025 – Batch Code 250616B Farmhouse
    • #451 Made on 6/03/2025 – Batch Code 250603P Peppercorn
    • #453 Made on 6/16/2025 – Batch Code 250616 Mustard Seed

    Some cheese products were repackaged by grocery stores and markets, so the original label may not be present. In these instances, the grocery store label should say the brand of cheese.

    For additional information about the investigation of these E. coli infections, read the Washington State Department of Health’s announcement.

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    Tim Lantz

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  • FDA unveils drugs to receive expedited review in support of ‘national priorities’

    By MATTHEW PERRONE

    WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines the Trump administration deems as “supporting U.S. national interests.”

    The Associated Press

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  • Beloved Partner Of Marijuana Faces Recall

    Cinnamon’s recall hits cannabis fans hard — the beloved spice enhances marijuana mornings, nights, and everything between

    Cinnamon toast is one of life’s simple pleasures — warm, sweet, and nostalgic. As a good the combination of warm toast, sugar, butter and cinnamon brought smiles on a school morning. But for many cannabis enthusiasts, it has become more than a breakfast comfort; it’s a favorite flavor pairing enhancing both body and mind. So when news hit several this beloved partner of marijuana faces recall, fans of this perfect cannabis companion let out a collective groan: ARGH!

    RELATED: Cannabis Can Help PTSD

    The spice rack staple, prized for its sweet heat and cozy aroma, has long been used alongside marijuana for both culinary and wellness reasons. Whether sprinkled into a morning edible or infused in a nighttime tea, cinnamon doesn’t just taste good — it enhances how people experience cannabis.

    Cinnamon Toast

    Here’s why: cinnamon’s natural compounds, particularly cinnamaldehyde, are known to support metabolism and blood sugar balance, while its scent helps trigger a calm, focused state. When paired with cannabis strains contain mood-lifting terpenes like limonene or pinene, the result can be an energizing and joyful start to the day. Cinnamon-infused cannabis coffees or low-dose edibles are especially popular among millennials looking for a more natural “wake and bake” which doesn’t leave them groggy.

    At night, the combo flips. A cinnamon-chamomile tea blended with a relaxing cannabis strain rich in myrcene or linalool can help calm racing thoughts, ease muscle tension, and support better sleep. It’s a cozy ritual feeling more like self-care than indulgence — a perfect wind-down for the overstimulated generation.

    RELATED: Is Cannabis Now The #1 Sleep Aid

    But with the current recall affecting certain batches of ground cinnamon, many cannabis-friendly kitchens are pressing pause. The recall, linked to potential contamination concerns, is a reminder not all natural products are created equal. Experts recommend checking product labels and buying organic or certified-safe cinnamon when using it in cannabis recipes, tinctures, or infusions.

    While cinnamon might be off the menu temporarily, fans aren’t giving up on this spicy soulmate. After all, few things beat the comfort of a cinnamon-dusted edible or the aroma of cannabis and cinnamon wafting together through a kitchen on a lazy Sunday morning.

    Amy Hansen

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  • FDA Adds Label Warning to J&J’s and Legend Biotech’s Cancer Therapy

    The U.S. Food and Drug Administration approved on Friday labeling changes for the blood cancer therapy of Johnson & Johnson and its partner Legend Biotech to include a warning for a potentially fatal gastrointestinal condition.

    Such a warning appears on the medicine’s label and is the most serious issued by the FDA.

    The FDA said it received reports that some patients treated with Carvykti developed a serious gut inflammation called IEC-EC, which in some cases led to life-threatening complications like bowel perforation and sepsis.

    Reports were received from clinical trials and postmarketing adverse event data, the FDA said.

    IEC-EC is a form of inflammation of the intestines triggered by the immune system. It was observed weeks to months after CAR-T therapy treatment with Carvykti in both clinical trials and after approval, the regulator said.

    Symptoms included persistent diarrhea, stomach pain and weight loss, often requiring intensive care and immune-suppressing drugs.

    A spokesperson for Johnson & Johnson said: “With more than 8,500 patients treated, the overall benefit/risk for Carvykti continues to be favorable, demonstrating durable responses with statistically significant progression-free survival and overall survival benefits.

    “The Carvykti label was also updated to include data showing a superior overall survival benefit versus standard therapies… at nearly three years of follow-up in patients receiving one to three prior lines of therapy.”

    Carvykti was first approved in February 2022 and received expanded approval in April 2024 for adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy.

    Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, found in the bone marrow.

    The FDA also updated the “clinical studies” section of the drug’s prescribing information to include overall survival data from the late-stage trial.

    The interim data of the late-stage study showed a statistically significant improvement in survival for patients receiving Carvykti compared to those on standard therapy, with a median follow-up of 33.6 months.

    Despite the new safety concerns, the FDA said the overall benefit of Carvykti continues to outweigh the risks for its approved use.

    Reporting by Siddhi Mahatole in Bengaluru; Editing by Alan Barona and Muralikumar Anantharaman

    Reuters

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  • Pasta salad recall map shows new warning in 24 states

    Sprouts Farmers Market of Phoenix, Arizona, is recalling select lots of their Smoked Mozzarella Pasta Salad due to fears the product could be contaminated with Listeria monocytogenes.

    Newsweek reached out to the company via email on Thursday for comment.

    Why It Matters

    Numerous public health alerts and recalls have been initiated this year because of the potential for damaged products, foodborne illness, contamination and undeclared food allergens.

    Millions of Americans experience food sensitivities or allergies every year. According to the Food and Drug Administration (FDA), the nine “major” food allergens in the United States are eggs, milk, fish, wheat, soybeans, crustacean shellfish, sesame, tree nuts and peanuts.

    “Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women,” the alert warns in part.

    What To Know

    The alert notes that the recalled product was sold at the deli service bar and via the grab-and-go section of the store.
    The recalled product was distributed to Sprouts’ stores in Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Kansas, Louisiana, Maryland, Missouri, North Carolina, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming.

    The impacted pasta salad was sold in plastic containers or packaged directly from the deli counter, the alert notes.

    The UPC code for the recalled product sold from the grab-and-go sections is 2-15786-00000 with use-by dates ranging from October 10, 2025, to October 29, 2025. The UPC code for the recalled product sold via “Service Case” is 2-15587-00000 with use-by dates also ranging from October 10, 2025, to October 29, 2025.

    Below is a map showing the states impacted by the recall:

    What People Are Saying

    The alert in part: “This follows a recall initiated by Fresh Creative Foods, due to possible Listeria monocytogenes contamination of the pasta ingredient that was manufactured by Nate’s Fine Foods of Roseville, CA. This recall is being made with the knowledge of the U.S. Food and Drug Administration.”

    What Happens Next

    People who have purchased the recalled pasta salad are urged to dispose of the product or return it to the original place of purchase for a refund, the alert says.

    Customers with additional questions may contact the company via phone at 480-814-8016 on weekdays from 9 a.m. to 4 p.m. MT or by contact form.

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  • Nearly 4 Million Pounds of Chicken Corn Dogs Recalled Over Wood

    Foster Poultry Farms is recalling more than 3.8 million pounds of chicken corn dog products after wood was found in the batter, resulting in injuries.

    The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced the massive recall on Saturday, affecting approximately 3,843,040 pounds of products that may be contaminated with pieces of wood embedded in the batter. The Livingston, California-based establishment received numerous consumer complaints, with at least five reported injuries from consumption of the affected products.

    Newsweek reached out to Foster Poultry Farms via online submission form on Sunday for comment.

    Why It Matters

    This latest recall represents the second major corn dog contamination incident in just one week, signaling potential systemic safety failures within the processed meat industry.

    On September 28 the Hillshire Brands Company issued an even larger recall of approximately 58 million pounds of corn dog and sausage on a stick product, also due to wood contamination that injured five consumers

    The contamination involves pieces of wood embedded in the batter of corn dogs, creating a serious injury risk for anyone consuming these products. With distribution reaching schools and military facilities nationwide, the recall highlights the potential for widespread health impacts when safety protocols fail in large-scale food production.

    What To Know

    The Foster Farms recalled chicken corn dog products were manufactured between July 30, 2024, and August 4, 2025, and were sold under various brand names, including “Chicken Corn Dogs Batter Wrapped Chicken Frankfurters on a Stick” and “Corn Dogs Chicken Franks Dipped in Honey Batter.”

    Consumers can identify affected products by looking for the establishment number “P-6137B” printed either inside the USDA mark of inspection or on the packaging.

    The products were distributed to retail and institutional locations across the United States, including Department of Defense facilities and through USDA Commodity Foods donations. While some products reached schools through commercial sales, FSIS clarified they were not part of food provided by the USDA for the National School Lunch Program.

    The contamination was discovered after FSIS received a consumer complaint involving an injury, prompting further investigation that revealed multiple additional complaints to the company. The establishment received numerous consumer complaints, with five specifically involving injuries from wood pieces found in the products.

    FSIS has classified this as a serious health risk, with officials expressing particular concern that affected products may still be stored in consumers’ refrigerators and freezers, as well as in institutional storage facilities.

    The agency emphasized that these products should not be consumed under any circumstances and should be immediately discarded or returned to the place of purchase for a refund.

    A full list of the products subject to recall can be found here.

    What Should Consumers Do?

    Consumers who have experienced injuries or health issues related to these products are advised to seek immediate medical attention and report their experiences through the Electronic Consumer Complaint Monitoring System at https://foodcomplaint.fsis.usda.gov/eCCF/, available 24 hours a day.

    The USDA Meat and Poultry Hotline (888-674-6854) remains available for food safety questions and concerns.

    What Happens Next?

    FSIS will conduct comprehensive recall effectiveness checks to verify that Foster Farms properly notifies all customers and takes necessary steps to ensure the contaminated products are completely removed from commerce.

    The agency will post retail distribution lists on its website at www.fsis.usda.gov/recalls as they become available, allowing consumers to check if their local stores received the affected products.

    Reporting from the Associated Press contributed to this article.

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  • Pet treat recall prompts new warning to customers 

    Best Buy Bones, Inc., is recalling four lots of Nature’s Own brand of Pet Chews Bully Bites pet treats in 1-pound packages, due to fears the product could be contaminated with salmonella.

    Why It Matters

    Numerous public health alerts and recalls have been initiated this year because of the potential for damaged products, foodborne illness, contamination and undeclared food allergens.

    Millions of Americans experience food sensitivities or allergies every year. According to the Food and Drug Administration (FDA), the nine “major” food allergens in the United States are eggs, milk, fish, wheat, soybeans, crustacean shellfish, sesame, tree nuts and peanuts.

    “Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products,” the alert warns in part.

    What To Know

    The alert says that 34 bags of the recalled product were distributed in Minnesota and then sold in stores in Wisconsin after September 23, 2025.

    The Nature’s Own Pet Chews Bully Bites have a UPC number of 739598900750 and packaged in 16-ounce bags with a resealable plastic pouch, the alert says.

    There have been no reported illnesses in dogs related to the recall as of Friday, the alert notes.

    The recalled product has a best-by date of September 2027, and the impacted lot numbers are 19379, 19380, 19381 and 19382.

    What People Are Saying

    The alert in part: “The health risk was discovered when samples of the product were collected on September 11, 2025, and tested by the Food and Drug Administration. The product tested positive for Salmonella. The company has ceased production and distribution of this product as the FDA, and the company continue their investigation into what caused the problem.”

    Arnold Mcintyre, chief operating officer of Best Buy Bones, Inc., to Newsweek via phone on Friday: “We have identified locations of all 34 bags and are now waiting on confirmation they have been destroyed.”

    What Happens Next

    People who have purchased the product are advised to dispose of it in a manner that children, wildlife and pets cannot access it, or return it to the original place of purchase, the alert says.

    “Do not sell or donate the recalled products. Do not feed the recalled product to pets or any other animals. Wash and sanitize pet food bowls, cups, and storage containers,” the alert notes.

    Customers with additional questions may contact the company via phone at 810-687-2106 from 8 a.m. to 5 p.m. ET Monday to Thursday.

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