The same bacteria that led to the 2022 baby formula recall and sparked shortages across the U.S., this year has caused the death of one newborn in Kentucky and brain damage in a Missouri infant, according to federal health officials.

Food and Drug Administration (FDA) officials confirmed Thursday that two cases of life-threatening infections caused by Cronobacter sakazakii have been reported in 2023, both babies who consumed powdered formula made by Abbott Nutrition, the company involved in the 2022 recall. For the reported cases this year, both Abbott and the FDA have found no link to the formula maker’s facilities, saying contamination likely happened after the containers were opened at home.

In February 2022, Abbott initiated a voluntary recall of its powder baby formulas for brands including Similac, Alimentum and EleCare that were manufactured at one of the company’s facilities in Sturgis, Michigan. The recall was due to the presence of Cronobacter sakazakii, which is a rare bacteria that the U.S. Centers for Disease and Control and Prevention (CDC) said has been found in powdered infant formula, skimmed milk powder, herbal teas and starches, and is “lethal for infants and can be serious among people with immunocompromising conditions and the elderly.”

The FDA said on Thursday that there was no reason to issue new recalls for baby formula after an investigation found, despite two infants becoming infected by the bacteria this year, there was no evidence that the infections were linked to manufacturing, the Associated Press reported.

“There is no indication of a broader public health concern related to this product at this time,” the FDA said in a statement.

Newsweek reached out via email on Saturday to the FDA and CDC for comment.

A photo of powdered baby formula. The FDA and CDC confirmed on December 7, 2023, that two cases of dangerous infections caused by cronobacter sakazakii have been reported this year, both in babies who consumed powdered formula made by Abbott Nutrition.
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In March, then 6-week-old Mira White, of Sikeston, Missouri, was diagnosed with a serious brain infection caused by the bacteria, which was found in an open container of Similac NeoSure formula in the baby’s home, according to the AP.

Mira’s mom told the AP that since her daughter became infected, she has suffered numerous seizures and said that brain scans show neurological damage caused by the infection.

In Kentucky, health officials notified the CDC in November that a baby who consumed Similac Total Comfort powdered formula had died after being infected with Cronobacter sakazakii, according to the AP.

John Koval, a spokesperson for Abbott, told Newsweek in an email on Saturday night that the reported infections in Missouri and Kentucky have not been linked to the company’s manufacturing facilities.

“As Abbott and FDA have said, the unopened product was tested and came back negative, and the infections have not been linked to the manufacturing environment,” Koval said. “Cronobacter is naturally and commonly found in the environment, and can find its way into infant formula after the packaging is opened. We encourage parents and caregivers to consult resources published by the FDA and CDC on how to safely handle, store and prepare infant formula.”

What is Cronobacter sakazakii?

Cronobacter sakazakii is a germ found naturally in the environment and can live in dry foods, including powdered infant formula and powdered milk, according to the CDC.

The CDC notes that powdered formula is not sterile, meaning it could become accidentally contaminated during the manufacturing process or after the container is opened at home.

Cronobacter sakazakii can live on surfaces, such as kitchen counters or sinks, and in water, according to the CDC.

Frequently and thoroughly cleaning surfaces, hands and baby products help reduce the risk. The CDC also advises parents to avoid setting formula scoops on the counter or in the sink, to keep lids and scoops clean and completely dry, and close containers of formula as soon as possible after using them.

What is the risk?

While the CDC states that Cronobacter infections are rare, they can be life-threatening in newborns. Serious infections in babies usually occur in the first few weeks of life.

Yearly, between two to four cases are reported to the CDC, which adds that this figure may not reflect the true number of illnesses because most hospitals and laboratories are not required to report Cronobacter infections to health departments.

Infants who are born prematurely and babies with weakened immune systems are more likely to develop serious symptoms if infected.

Signs of Cronobacterillness in babies usually start with a fever and poor feeding, excessive crying, or very low energy, according to the CDC, which warns that some infants may also have seizures. An infant with these symptoms should be seen by a medical provider as soon as possible.

Cronobacter germs can lead to sepsis, a dangerous blood infection, and cause the lining surrounding the brain and spinal cord to swell, also known as meningitis. Babies younger than two months are most at risk for developing meningitis if they get sick from Cronobacter.