Toothpaste recalled nationwide as FDA issues risk warning

A nationwide recall of more than 40,000 units of toothpaste has received the lowest risk level by the Food and Drug Administration.

A recall for Sensodyne Pronamel Active Shield Toothpaste for Sensitive Teeth began on August 5 over concerns that “Fresh Mint” tubes were mislabeled “Cool Mint/Whitening.” The outer carton was labeled accurately.

FDA inspectors classified the recall as a Class III, the lowest of three risk levels, on Tuesday, indicating the mix-up was “not likely to cause adverse health consequences.”

Newsweek contacted Haleon, which makes Sensodyne, via email on Tuesday.

Why It Matters

The FDA assigned this recall a Class III designation, which applies to situations where the use of or exposure to the recalled product is not likely to cause adverse health consequences. While the FDA determined the risk to be minimal, the corrective move underscores the regulatory attention to food contact safety and manufacturing consistency.

What To Know

The FDA recall entry listed the product as Sensodyne Pronamel (potassium nitrate 5 percent, sodium fluoride 0.25 percent) Active Shield Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4 ounces (96.4 grams).

The product came in cases containing six tubes, and the recall affected 46,692 tubes, the FDA alert said.

It added that the products were recalled by New York-based Haleon U.S. Holdings after having been distributed nationwide by GSK Consumer Healthcare.

The FDA’s new classification record listed the recall reason as “labeling.”

“Label Mix-up: The outer carton is labeled Fresh Mint. The tube is labeled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton,” the alert said.

The recall entry included lot and expiration information. The case lot number is 5058RB, and the carton and tube lot number is NJ2A. Both had an expiry date of August 31, 2027.

FDA inspectors carry out a hazard assessment before issuing one of three risk levels. The three classifications are these:

• Class I—a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III—a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

What People Are Saying

The Food and Drug Administration said on its website: “Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any medication or device. Problems with product quality may occur during manufacturing, shipping, or storage. They include … labeling concerns.”

What Happens Next

The FDA lists the recall as ongoing. The alert did not provide consumer return or disposal instructions.