More Than 4 Million Tubes of Toothpaste Recalled Nationwide, Including Children's Brands
The FDA has classified the recall of 17 toothpaste varieties, many of them children's pastes sold under Barbie, Hot Wheels, My Little Pony and Crayola branding, as Class II after manufacturing practice deviations at the maker.
Key points
- More than 4.3 million tubes of toothpaste sold across the United States are under a nationwide recall, and most of them were made for children.
- The Food and Drug Administration told USA Today by email on Thursday, October 22 that the recall was initiated on September 10 by Pritam International, the manufacturer, and that the agency…
- The stated reason for the recall is deviations from current good manufacturing practice requirements.
More than 4.3 million tubes of toothpaste sold across the United States are under a nationwide recall, and most of them were made for children. The recall covers 17 varieties sold under the Brush Buddies, evo and ARU brands, including children's anticavity pastes carrying Barbie, Hot Wheels, My Little Pony and Crayola branding, along with ice cream flavored pastes such as vanilla and mint chocolate chip.
The Food and Drug Administration told USA Today by email on Thursday, October 22 that the recall was initiated on September 10 by Pritam International, the manufacturer, and that the agency classified it as a Class II recall on October 19. The products were distributed nationwide by Ashtel Studios.
Why the tubes were pulled
The stated reason for the recall is deviations from current good manufacturing practice requirements. Those rules are the basic quality standards for how drug products, including fluoride toothpaste, must be made and checked. The FDA listings do not say the toothpaste was contaminated, and no injuries had been reported in the sources checked for this story.
A Class II classification sits in the middle of the FDA scale. It means using the product could cause temporary or medically reversible health effects, while the chance of serious harm is considered remote. It is a step below the most serious Class I level, where a product could cause serious injury or death.
What shoppers should check
The recalled pastes came in flavors aimed at children, among them bubble gum and strawberry, and in the ice cream flavor lines sold under the same brands. Because the recall turns on specific products and lots, the practical step for parents is to compare the brand and product name on the tube at home against the FDA enforcement report listing before using it again.
Children's toothpaste is a small purchase that families repeat without thinking much about it, which is part of why a recall of this size matters. More than four million tubes is a large share of the character branded children's pastes on store shelves, and the tubes were distributed across the whole country rather than in one region.
The recall listings name Pritam International as the recalling firm and Ashtel Studios as the United States distributor. Neither the FDA classification nor the news reports carried any report of a child or adult being harmed by the products. Anyone who finds a recalled tube at home should stop using it and follow the FDA listing for the product involved.
Timeline
- Sep 10, 2026Pritam International initiates the voluntary recall of the toothpaste varieties over manufacturing practice deviations.
- Oct 19, 2026The FDA classifies the recall as Class II, its middle risk level, meaning temporary or medically reversible effects are possible and serious harm is remote.
- Oct 22, 2026The FDA confirms the recall details to USA Today by email as nationwide coverage puts the total at more than 4.3 million tubes in 17 varieties.