FDA Classifies Recall of More Than 4 Million Toothpaste Tubes

More than 4 million tubes of toothpaste are included in a voluntary recall initiated by Pritam International Private Limited on Sept. 10, according to a U.S. Food and Drug Administration enforcement report. The FDA classified the recall as Class II on Oct. 19, covering products distributed nationwide.

The recalled products include several varieties of Brush Buddies children's toothpaste, along with two Evo products marketed for teeth whitening and sensitivity and two Aru products promoted for gum health and cavity protection, according to the FDA.

The agency's enforcement report identifies multiple children's toothpaste varieties, including products featuring Hot Wheels and My Little Pony themes. Other affected Brush Buddies varieties include chocolate ice cream, cookies 'n cream, and mint chocolate chip flavors.

The FDA has not disclosed the reason for the recall. USA TODAY contacted the agency for additional information, but the agency had not immediately responded to the request at the time of publication.

The FDA defines a Class II recall as "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."

The classification indicates that exposure to an affected product may result in temporary or medically reversible health effects, while the probability of serious adverse health consequences is considered remote under the FDA's definition.

The enforcement report contains identifying details for the recalled products, including recall number codes and expiration dates. These details help distinguish affected varieties from other toothpaste products.