Over 4 million toothpaste tubes recalled nationwide due to manufacturing violations

Federal regulators have issued a nationwide recall affecting more than 4.3 million tubes of fluoride toothpaste—including several popular character-themed and flavored varieties marketed to children—over manufacturing compliance failures.

The recall covers 17 distinct products manufactured by India-based Pritam International Private Limited and distributed across the United States by Ontario, California-based Ashtel Studios Inc.

The U.S. Food and Drug Administration (FDA) classified the action as a Class II recall, indicating that while exposure to the products could cause temporary or medically reversible health issues, the probability of serious adverse health consequences remains low. No confirmed illnesses or injuries have been reported to date.

According to FDA enforcement notices, the action was prompted by “Current Good Manufacturing Practice (CGMP) deviations”—a regulatory term signifying that the manufacturer failed to adhere to federal standards governing the testing, processing, packaging, or storage of drug-grade products. Because fluoride is regulated as an active drug ingredient in the United States, fluoride toothpastes are held to strict over-the-counter pharmaceutical manufacturing guidelines.

Affected Toothpaste Brands and Products

The recall spans multiple children’s and adult formulas sold under the Brush Buddies, evo, and ARU brand names. Expiration dates for affected lots range from November 2026 through December 2028:

• Brush Buddies Character Flavors (4.0 oz):

  • Hot Wheels Strawberry Flavor (UPC: 8 10147 88047 8)

  • Crayola Silly Scents Bubble Gum Flavor (UPC: 8 50048 32731 3)

  • Crayola Silly Scents Watermelon Flavor (UPC: 8 50048 32730 6)

  • Crayola Silly Scents Strawberry Flavor (UPC: 8 50048 32732 0)

  • My Little Pony Scents Bubble Gum Flavor (UPC: 8 10147 88270 0)

• Brush Buddies Ice Cream Flavors (3.5 oz):

  • Vanilla Ice Cream Flavored (UPC: 8 10147 88517 6)

  • Mint Chocolate Chip Ice Cream Flavored (UPC: 8 10147 88520 6)

  • Cookies ’n Cream Ice Cream Flavored (UPC: 8 10147 88519 0)

  • Chocolate Ice Cream Flavored (UPC: 8 10147 88518 3)

• Adult & Whitening Formulas (3.5 oz):

  • Brush Buddies Whitening with Baking Soda, Cool Mint (UPC: 8 50010 84249 3)

  • BB (Brush Buddies) Cavity Protection, Cool Mint 2-Value Pack (UPC: 8 10147 88543 5)

  • BB (Brush Buddies) Advanced Whitening, Peppermint (UPC: 8 10147 88542 8)

  • evo Advanced Whitening, Peppermint (UPC: 8 10147 88619 7)

  • ARU Gum Health Soothing Mint, Stannous Fluoride 0.45% (UPC: 8 10147 88786 6)

  • ARU Cavity Protection Cool Mint, Sodium Fluoride 0.243% (UPC: 8 10147 88785 9)

Consumer Guidance

Health officials advise consumers to inspect their medicine cabinets and bathrooms for any of the listed UPC codes and matching lot numbers.

Anyone in possession of a recalled tube is advised to stop using it immediately and safely discard it or return it to the place of purchase for a replacement or refund. Parents who suspect their child experienced an adverse reaction should consult their pediatrician or dental care provider.