FDA Classifies Recall of 4.3 Million Toothpaste Tubes, Including Kids' Brands, as Class II

More than 4.3 million tubes of toothpaste are under recall, and a big chunk of them are made for kids.

Pritam International Private Limited, based in India, voluntarily started the recall on Sept. 10. On Monday, Oct. 19, the FDA classified it as Class II, according to the agency's enforcement report.

The products are distributed in the U.S. by Ashtel Studios Inc., a California company.

What is being recalled

The recall covers 17 toothpaste products sold under the Brush Buddies, BB, evo and ARU brands.

The kids' lines carry licensed characters including Barbie, Hot Wheels, Crayola and My Little Pony. Flavors include vanilla ice cream, chocolate ice cream, bubble gum, mint chocolate chip and cookies and cream.

The adult-oriented products include ARU gum health and cavity protection toothpaste, plus evo sensitive and advanced whitening lines.

Expiration dates on the affected tubes run from December 2026 through 2028, according to one report; another puts the range at November 2026 through June 2028. Not every tube sold under these brand names is included. The lot number and expiration date printed on the package have to match the FDA's recall listing.

Why the FDA acted

The FDA lists the reason as deviations from Current Good Manufacturing Practice regulations, known as CGMP. These regulations outline the minimum requirements for the facilities, methods and controls used to manufacture, process and package drug products.

The agency has not said which specific practices Pritam failed to follow. It has not said whether any contamination, wrong ingredient levels or other defect was found in the product itself. No illnesses or injuries tied to the toothpaste have been disclosed.

The FDA describes CGMP this way: "Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products."

What Class II means

The FDA defines a Class II recall as one where "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

The FDA's second-highest risk category, a Class II designation means the agency considers serious harm unlikely. It also means there is some risk, or the recall wouldn't exist.

What buyers should do

Anyone who bought one of these products should stop using it and compare the packaging against the FDA's recall listing. Consumers can discard affected tubes or contact the retailer or distributor about possible refunds or replacements. The FDA's recall notice does not include specific consumer instructions, and one report says neither the manufacturer nor the distributor has issued public guidance on returns or refunds.

Parents are encouraged to check toothpaste bought for children first, particularly products featuring cartoon characters or candy-inspired flavors.

Companies and silence

Ashtel Studios did not respond to The Epoch Times' request for comment. People says it has asked Pritam for comment. Neither company has publicly explained the manufacturing problem.

A separate toothpaste matter from earlier this year is unrelated to this recall. On Jan. 8, Texas Attorney General Ken Paxton announced a settlement with Procter & Gamble over Crest children's packaging that showed excessive amounts of toothpaste. Paxton said at the time that "misleading images that show excessive amounts of fluoride toothpaste put children's health and brain development at risk." That case concerned marketing images, not manufacturing, and nothing ties it to Pritam or Ashtel.

The FDA has not answered the key question: what exactly went wrong at the plant. Until the agency or the companies say, shoppers have only lot numbers to go on. The recall listing on the FDA's website carries the full list of recall numbers and expiration dates.