The United States Food and Drug Administration (FDA) has classified a nationwide recall of more than four million tubes of toothpaste as Class II after identifying manufacturing violations involving products sold under three brands.
The recall affects 17 varieties manufactured by India-based Pritam International Private Limited and distributed in the United States by Ashtel Studios Inc. The products include Brush Buddies, evo and ARU toothpastes, with several varieties marketed specifically to children.
The FDA initially recorded the voluntary recall on September 10, 2026, before classifying it as Class II on October 19.
A Class II classification means exposure to or use of the affected products could cause temporary or medically reversible health consequences, while the likelihood of serious harm is considered remote.
The agency cited deviations from Current Good Manufacturing Practice (CGMP), regulations designed to ensure medicines meet required standards for identity, quality, strength and purity. However, the FDA has not publicly specified the precise manufacturing failures involved in this case.
Affected products include character-themed toothpastes featuring Barbie, Hot Wheels, Crayola and My Little Pony, as well as ice-cream-flavoured varieties. The recall also covers adult formulations marketed for whitening, sensitivity relief, gum health and cavity protection.
Consumers are advised to check their toothpaste against the affected product list and stop using any recalled item. They can dispose of the products or seek a refund or replacement from the retailer or manufacturer.
The recall applies to products distributed in the United States. Consumers elsewhere should check local product information and consult relevant health authorities if they believe they have purchased an affected item.
