The FDA Classified a Recall of More Than 4.3 Million Toothpaste Tubes, Including Kids’ Barbie, Hot Wheels and My Little Pony Brush Buddies Varieties

About 1.8 million of the recalled tubes carry characters children ask for by name: Barbie, Hot Wheels, Crayola and My Little Pony. They are part of a recall of more than 4.3 million tubes of fluoride toothpaste, 4,301,700 in all, that the Food and Drug Administration classified as Class II on Oct. 19, 2026, and many of them may already be sitting next to a bathroom sink.

The recall covers 17 products sold under the Brush Buddies, evo and ARU names. No illnesses or injuries have been reported, but families can compare the product names, lot codes and expiration dates on their own tubes.

Who Recalled the Toothpaste and Why

According to the FDA enforcement report entry for the recall, the recalling firm is Pritam International Private Limited, a manufacturer based in India, which started the recall on Sept. 10. The products were distributed nationwide by Ashtel Studios Inc. of Ontario, California.

The stated reason is “CGMP deviations,” shorthand for departures from the current good manufacturing practice rules that fluoride toothpaste makers must follow. The FDA has not said publicly which specific manufacturing problems were found. FOX 9 reported that the FDA notice lists no illnesses or injuries linked to the toothpaste, and that the affected tubes come in 3.5-ounce and 4-ounce sizes, plus a two-pack of 3.5-ounce tubes.

The Class II label has a specific meaning. The FDA’s recall definitions describe it as a situation where using a product may cause temporary or medically reversible health effects, or where the chance of serious harm is remote. It sits in the middle of the agency’s three recall classes, below the most serious category and above the one where harm is considered unlikely.

The timeline explains why many families are only hearing about the recall now. Pritam International began pulling the products on Sept. 10, but the recall reached wide public attention only after the FDA assigned its classification on Oct. 19. Of the 17 products, 13 carry the Brush Buddies name.

News reports on this recall have relied on the agency’s enforcement entry rather than a retailer notice or a public statement from the manufacturer. That leaves the job of checking largely to the people who bought the toothpaste.

The Children’s Varieties in the Recall

The character toothpastes make up a large share of the total. The tube-by-tube breakdown published by The Healthy, drawn from the FDA report, lists these 4-ounce children’s products:

• Brush Buddies Barbie Bubble Gum: 409,800 tubes
• Brush Buddies Hot Wheels Strawberry: 411,600 tubes
• Brush Buddies Crayola Silly Scents in Bubble Gum, Watermelon and Strawberry: 320,232 tubes of each flavor
• Brush Buddies My Little Pony Scents Bubble Gum: 17,400 tubes

Four ice cream flavors of Brush Buddies toothpaste are also included, at 112,092 tubes each: Vanilla, Mint Chocolate Chip, Cookies ‘n Cream and Chocolate. Those come in 3.5-ounce tubes.

The Whitening and Mint Tubes on the List

The largest single item is not one of the character tubes. Brush Buddies Whitening Cool Mint with Baking Soda accounts for 797,868 tubes. The list also includes Brush Buddies Advanced Whitening Peppermint (198,288 tubes) and a two-pack of Brush Buddies Cavity Protection Cool Mint (231,936 packs).

Two evo products are covered: Advanced Whitening Peppermint (405,336 tubes) and Sensitive Sweet Mint (389,880 tubes). Two ARU products, Gum Health Soothing Mint and Cavity Protection Cool Mint, account for 15,264 tubes each.

The expiration dates on affected lots run from November 2026 through June 2028. Some of these brands are sold at Walmart and Dollar Tree, The Healthy noted, but the FDA report does not say which stores carried the recalled lots.

How Families Can Check Their Tubes

The recall applies to specific lots, not every tube of each product. Families can match the lot number and expiration date on each tube or box against the lots listed in the FDA’s enforcement report. A tube that matches should be set aside, and the store or the distributor can be contacted about a return.

Switching to another fluoride toothpaste does not interrupt a child’s routine. The American Dental Association recommends a smear about the size of a grain of rice from the time the first tooth comes in until age 3, and a pea-sized amount for children ages 3 to 6. The ADA also recommends that caregivers supervise brushing so children spit the paste out rather than swallow it. It adds that every cavity-protection toothpaste with the ADA Seal of Acceptance must contain fluoride, so the Seal is one way to choose a replacement.

This is the latest in a string of fall recalls affecting family homes, after the Costway high chair recall and the federal warning on Power Quick Pot pressure cookers. Earlier this month, the FDA also flagged a baby gripe water for unlisted alcohols.

What Is Still Unknown

The FDA has not released which manufacturing practices fell short or whether any recalled tubes were found to be contaminated or mislabeled. ConsumerAffairs reported that the agency has not identified the specific problems publicly. The FDA’s recall definitions also note that recalls can be carried out on a firm’s own initiative, at the agency’s request or by FDA order; this one was started by the manufacturer. Until more details are released, the lot list remains the only way for families to know whether the toothpaste in their home is part of the recall.

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This article was produced with AI assistance and edited for accuracy against the sources linked above.

Image: Thegreenj – CC BY-SA 3.0/Wikimedia Commons