FDA recalls 17 toothpaste varieties nationwide, affecting over 4 million tubes, including children's flavors and whitening products

The FDA has recalled over 4 million tubes of toothpaste nationwide. As per the agency, the majority of recalled products are sold under the Brush Buddies brand name, and it also contains several products that are marketed for children.

The 17 types of items listed were voluntarily recalled by an India-based firm, Pritam International Private Limited, on September 10. Although it is not known why exactly the massive recall was initiated, as per the FDA, it is because of “CGMP Deviations.” CGMP is the Current Good Manufacturing Practice regulations that the FDA enforces.

And “if a company is not complying with CGMP regulations, any drug it makes is considered ‘adulterated’ under the law,” FDA’s FAQ page states. “This kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It does not mean that there is necessarily something wrong with the drug.”


FDA labeled all the recalled products as Class II on October 19. As per the agency, it “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Other than the Brush Buddies toothpastes, the list of 17 items also includes two evo products, which are sold for whitening and sensitivity, and two ARU toothpastes for gum health and anticavity.

Brush Buddies’ “Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda” has the largest number of tubes, with a whopping 797,868 pulled from shelves.

Here’s a checklist for the 17 types of recalled toothpaste tubes:

• Brush Buddies: Barbie, Bubble Gum Flavor
• Brush Buddies: Hot Wheels, Strawberry Flavor
• Brush Buddies: Crayola, Silly Scents, Bubble Gum Flavor
• Brush Buddies: Crayola, Silly Scents, Watermelon Flavor
• Brush Buddies: Crayola Silly Scents, Strawberry Flavor
• Brush Buddies: My Little Pony Scents, Bubble Gum Flavor
• Brush Buddies: Vanilla Ice Cream Flavored
• Brush Buddies: Mint Chocolate Chip Ice Cream Flavored
• Brush Buddies: Cookies ‘n Cream Ice Cream Flavored
• Brush Buddies: Chocolate Ice Cream Flavored
• Brush Buddies: Whitening Anti-cavity Fluoride Toothpaste with Baking Soda
• Brush Buddies: Cavity Protection, Anti-Cavity Fluoride Toothpaste, Cool Mint
• Brush Buddies: Advanced Whitening, Anti-Cavity, Peppermint
• Evo: Advanced Whitening, Anticavity Fluoride Toothpaste, Peppermint
• Evo: Sensitive, Anticavity Fluoride Toothpaste, Sweet Mint
• ARU: Toothpaste, Gum Health, 9 Ingredients, Soothing Mint
• ARU: Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint

To access the full list, you can visit the FDA page.