# FDA toothpaste recall by Pritam International

> Live situation record from CLSTR: https://clstr.news/situations/fda-toothpaste-recall-by-pritam-international
> Updated: 2026-10-26T09:25:38.000Z. Sources: 17. Developments: 3.

The U.S. Food and Drug Administration (FDA) issued a Class II recall for approximately 4.3 million tubes of fluoride toothpaste. The voluntary recall was initiated by Pritam International Private Limited, an Indiana-based manufacturer with ties to Delhi, India, due to deviations from Current Good Manufacturing Practice (CGMP) standards.

The recall affects 17 different products distributed by Ashtel Studios Inc. of Ontario, California. Affected brands include Brush Buddies, Crayola, Hot Wheels, My Little Pony, Evo, ARU, and BB. Many of the products are marketed toward children and feature novelty flavors such as bubble gum, strawberry, watermelon, and various ice cream flavors. The recall also encompasses adult formulas designed for whitening, sensitivity, and cavity protection.

A Class II classification indicates that use of the products may cause temporary or medically reversible adverse health consequences. While the FDA noted that the likelihood of serious harm is considered low and no illnesses or injuries have been linked to the recall, consumers are advised to check expiration dates—ranging from November 2026 through June 2028—and return items to the place of purchase for a refund.

## Timeline

### 2026-10-26: FDA announces nationwide recall of 4.3 million toothpaste tubes

Over 4.3 million tubes of Brush Buddies, Evo, and ARU toothpaste are being recalled nationwide due to manufacturing deviations, including several children's character-themed brands.

2 sources. https://clstr.news/cluster/fda-announces-nationwide-recall-of-43-million-toothpaste-tubes

### 2026-10-23: FDA recalls 4.3 million tubes of toothpaste due to manufacturing violations

The FDA has recalled over 4 million tubes of toothpaste, including children's brands like Crayola and Hot Wheels, due to manufacturing violations by India-based Pritam International.

2 sources. https://clstr.news/cluster/fda-recalls-43-million-tubes-of-toothpaste-due-to-manufacturing-violations

### 2026-10-21: FDA recalls over 4.3 million tubes of toothpaste nationwide

The FDA has issued a Class II recall for over 4.3 million tubes of fluoride toothpaste from brands including Brush Buddies, Crayola, and Hot Wheels due to manufacturing standard deviations.

13 sources. https://clstr.news/cluster/fda-recalls-over-43-million-tubes-of-toothpaste-nationwide

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Cite as: FDA toothpaste recall by Pritam International. CLSTR, https://clstr.news/situations/fda-toothpaste-recall-by-pritam-international