FDA Toothpaste Recall: More Than 4 Million Tubes, Including Kids’ Brands

A toothpaste recall affecting more than 4 million tubes has gained renewed attention after the U.S. Food and Drug Administration classified it as Class II, a category used when exposure may cause temporary or medically reversible health effects, or when the chance of serious harm is considered remote. The products include children’s toothpaste featuring characters such as Barbie, Hot Wheels, Crayola and My Little Pony, along with adult products sold under the evo and ARU brands.

The recall was initiated by Pritam International Private Limited on September 10. The company manufactured the toothpaste in India, and Ashtel Studios Inc. distributed it in the United States. The FDA’s October 19 classification is the latest development; it is not the date the recall began.

Which toothpaste products are included?

The recall covers 17 products: 13 under Brush Buddies, two under evo and two under ARU. The Brush Buddies products include children’s character-themed toothpastes, flavored varieties and adult toothpaste options.

The listed Brush Buddies products include:

• Barbie Bubble Gum and Hot Wheels Strawberry anticavity toothpastes

• Crayola Silly Scents toothpaste in Bubble Gum, Watermelon and Strawberry flavors

• My Little Pony Scents Bubble Gum toothpaste

• Vanilla Ice Cream, Mint Chocolate Chip, Cookies ’n Cream and Chocolate Ice Cream flavored toothpastes

• Whitening toothpaste with Baking Soda in Cool Mint

• Cavity Protection toothpaste in a Cool Mint two-pack

• Advanced Whitening toothpaste in Peppermint

The recall also includes evo Advanced Whitening Peppermint and evo Sensitive Sweet Mint toothpastes, plus ARU Gum Health Soothing Mint and ARU Cavity Protection Cool Mint toothpastes.

A product name alone may not confirm whether a tube is affected. The FDA report includes product identifiers and lot information, so consumers should compare the tube’s details with the official entry before deciding it is outside the recall.

Why were the toothpastes recalled?

The stated reason is deviations from Current Good Manufacturing Practice, or CGMP. These standards cover how drug products are made and controlled to help ensure their identity, strength, quality and purity. The recall information cited in the reports does not identify a specific contaminant or explain which manufacturing requirements were not met.

That distinction matters. The recall and its Class II classification call for consumers to check the products, but the public notice does not say that every tube is contaminated or that consumers who used one will become ill. Class II describes the FDA’s assessment of the potential health risk associated with exposure to a violative product.

"The FDA announced a voluntary nationwide recall of more than 4.3 million tubes of fluoride toothpaste. The recalled products were sold under brands including Brush Buddies, Crayola, Hot Wheels, My Little Pony, evo, ARU and BB. The recall involves multiple flavors, sizes and expiration dates and was initiated because of current good manufacturing practice deviations. What you can do: Consumers who have recalled products should stop using them and contact the retailer or manufacturer for information about returns or refunds."

— Fluoride Action Network (@FluorideAction) October 21, 2026

What does a Class II recall mean?

The FDA defines a Class II recall as one in which exposure may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Class I is the category for a reasonable probability of serious harm or death; Class III applies when adverse health consequences are unlikely.

The Class II label is not a guarantee that every affected product will cause harm, nor does it mean the issue can be ignored. It is the FDA’s risk classification for the recall. Consumers should identify whether their specific tube appears in the product and lot information.

What should consumers do if they have one of the products?

If a tube matches an affected product, stop using it while you check the FDA’s recall entry for its product identifiers and lot details. The article reporting the recall says the FDA did not provide product-specific consumer instructions. Consumers seeking a refund, replacement or guidance on disposal can contact the retailer or Ashtel Studios.

If someone has a health concern after using a recalled product, they should contact a qualified health professional. The recall notice does not provide evidence that illness has occurred, so avoid assuming symptoms are linked without medical advice.

The FDA says its Enforcement Reports list recalls after they are classified and can be updated when details such as classification, reason or product information change. Consumers can check the agency’s entry for Event 99849 for the latest product and lot information.