Recall for Prescription Toothpaste

A label mix-up has prompted Elevate Oral Care to recall a single lot of Just Right 5000 toothpaste, according to the September 18, 2024, US Food and Drug Administration (FDA) Enforcement Report. The report provided no specific details about the label mistake.

The recall affects Just Right 5000 toothpaste, 1.1% sodium fluoride, candy apple flavor, 3.4 oz/ 97 g (NDC 57511-0002-1), from lot G073DC (Exp. 3/31/26). The product was manufactured in the United States, with an imported pump, for Elevate Oral Care, West Palm Beach, Florida. The toothpaste was distributed to 120 direct customers throughout the United States.

Elevate Oral Care voluntarily initiated the recall on August 20, 2024. On September 12, 2024, the FDA designated the recall Class III. Per the recall classification, use of the affected toothpaste is not likely to cause harm.

Just Right 5000 is a prescription toothpaste for pediatric patients with oral health risk.