FDA Classifies Recall of Over 4.3 Million Toothpaste Tubes, Including Kids' Brands

The U.S. Food and Drug Administration classified a recall of more than 4.3 million tubes of toothpaste as Class II on October 19, 2026. The recalled products are sold under the Brush Buddies, evo and ARU brand names and include lines marketed to children, according to the FDA's enforcement report and reporting by CBS12 and NBC Chicago.

Who Is Behind the Recall

The recalling firm is Pritam International Private Limited, a manufacturer based in India. The toothpaste was distributed across the United States by Ashtel Studios Inc., a company based in Ontario, California, according to CBS12 and NBC News. Pritam initiated the recall voluntarily on September 10, 2026; the FDA assigned its Class II classification on October 19, roughly six weeks later.

The FDA's stated reason for the recall is "current good manufacturing practice" (CGMP) deviations — meaning the production facility did not follow all of the agency's required manufacturing standards. Neither the FDA's public notice nor the news outlets that reviewed it specified exactly which deviations triggered the action, and the FDA has not reported any illnesses or injuries linked to the products, per NBC News.

What a Class II Recall Means

The FDA assigns recalls to one of three classes based on risk. A Class II recall, the designation given here, means that use of or exposure to the product "may cause temporary or medically reversible health effects," with the probability of serious adverse health consequences considered remote, according to CBS12's reporting on the FDA's classification system.

Which Products Are Affected

The recall spans 17 individual products, per NBC Chicago, covering both children's and adult toothpaste lines. CBS12 reported the recall covers 12 product lines; the discrepancy reflects how different outlets grouped flavor and character variants, but both describe the same underlying recall event.

• Brush Buddies character lines: Barbie, Hot Wheels, My Little Pony and Crayola Silly Scents, in flavors including vanilla, mint chocolate chip, cookies 'n cream, chocolate ice cream, strawberry, watermelon and bubble gum
• evo brand: whitening and sensitivity toothpaste formulas in flavors including peppermint and sweet mint
• ARU brand: cavity-protection and gum-health formulas

Specific lot numbers and expiration dates vary by product. Reported expiration dates for affected tubes range from November 2026 through June 2028, according to NBC News. The FDA's enforcement report lists individual lot codes for each product so households can check tubes already in use.

What the FDA and Retailers Have Said

The FDA's enforcement report does not include a direct quote from the agency beyond the standard classification language, and the news outlets that reviewed the filing did not cite additional agency commentary. No retailer statements were included in the sources reviewed for this report.

What Consumers Are Advised to Do

NBC News reported that consumers should stop using any affected toothpaste and check the brand, lot number and expiration date on their tube against the FDA's recall listing. As of the reporting reviewed, no formal refund process had been announced by the companies involved.

What Remains Unknown

The FDA has not publicly detailed the specific manufacturing practice violations that led to the recall, nor has it disclosed whether inspectors found the issues during a routine audit or in response to a complaint. The agency's notice also does not specify which U.S. states received the affected shipments, describing distribution only as nationwide.