Toothpaste maker recalls more than 4.3 million tubes, including Barbie and Hot Wheels brands

Pritam International Private Limited is recalling over 4 million tubes of toothpaste marketed as Brush Buddies, Evo and ARU products because of departures from current good manufacturing practice requirements, according to the FDA.

The FDA classified the recall as Class II on Monday, according to NBC Chicago. Under the agency’s definition, exposure to a Class II product may result in “temporary or medically reversible adverse health consequences,” but serious harm is unlikely, according to Fox Business.

Ashtel Studios Inc., based in Ontario, California, distributed the toothpaste across the United States, and Pritam, an India-based company, began the recall on Sept. 10, according to NBC Chicago. The recall is ongoing, according to Fox Business.

The recalled Brush Buddies products carry Barbie, Hot Wheels, Crayola Silly Scents and My Little Pony branding. They include vanilla, mint chocolate chip, cookies 'n cream and chocolate ice cream flavors, plus whitening and cavity-protection varieties, according to NBC Chicago. Two Evo products for whitening and sensitivity and two ARU products for gum health and cavity protection are included as well.

Three Crayola Silly Scents varieties account for more than 960,000 tubes, according to Fox Business.

The FDA did not identify the particular deviations behind the recall. The agency referred any requests for specifics to the company, according to NBC Chicago.

The recall covers more than 4.3 million tubes across 17 products. Brush Buddies Whitening Anti-Cavity Fluoride Toothpaste with Baking Soda in Cool Mint is the largest single product, at 797,868 tubes. The Hot Wheels strawberry variety accounts for 411,600 tubes and the Barbie bubble gum variety for 409,800. The two ARU products are the smallest, at 15,264 tubes each.

Only specific lots are affected. The FDA notice lists lot numbers and expiration dates, which run from Nov. 30, 2026, to Dec. 4, 2028. The FDA gave no specific instructions for consumers and issued no press release for the recall.