FDA flagged recall of more than 4.3 million tubes of toothpaste

Pritam International Private Limited is recalling millions of tubes of toothpaste sold across the United States under the Brush Buddies, evo and ARU brands over deviations from current good manufacturing practice, the FDA said.

The recall covers more than 4.3 million tubes across 17 products, according to Newsweek. The FDA classified the recall as Class II on Monday. Pritam, based in Haridwar, India, initiated the voluntary recall on Sept. 10, and the recall remains ongoing.

Class II is the second-highest risk level, according to Health. It applies when a product could produce short-lived or medically correctable health effects, while the likelihood of serious harm is remote, according to Newsweek.

Ashtel Studios Inc., of Ontario, California, distributed the toothpaste. The Brush Buddies children's varieties include Barbie, Hot Wheels, Crayola Silly Scents and My Little Pony flavors. The line also has vanilla, mint chocolate chip, cookies 'n cream and chocolate ice cream flavors. The recall extends to evo Advanced Whitening and evo Sensitive toothpaste, as well as ARU Gum Health and ARU Cavity Protection. Products come in 3.5-ounce and 4-ounce tubes, and one is sold as a two-pack of 3.5-ounce tubes.

The largest single product is Brush Buddies Whitening Anti-Cavity Fluoride Toothpaste with Baking Soda in Cool Mint, with 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.

Specific lots are affected, and the FDA notice lists lot numbers and expiration dates for each product. Expiration dates on the affected lots run from Nov. 30, 2026, to Dec. 4, 2028.

The FDA did not specify the manufacturing deviations, according to Newsweek. Current good manufacturing practice requirements exist to guarantee that drugs are properly identified, potent, high-quality and free of contamination, according to Health. The FDA said no press release was issued for the recall.

The FDA gave no specific instructions for consumers. The safest option is to stop using the recalled toothpaste and either discard the tubes or send them back, according to Health.