Key Takeaway:
- 4.3 million toothpaste tubes recalled: The FDA classified the recall of 17 products under Brush Buddies, evo and ARU as Class II.
- Manufacturing violations prompted the recall: The FDA cited manufacturing-practice deviations but did not specify the exact defect.
- Check products before use: Consumers should verify product details, lot codes and expiration dates against the official FDA recall information.
The U.S. Food and Drug Administration has classified a nationwide recall of 4.3 million toothpaste tubes as Class II, citing manufacturing violations affecting 17 products sold under three brands.
Recall affects children’s and adult toothpaste
Pritam International Private Limited, an India-based manufacturer, initiated the voluntary recall on Sept. 10, according to the FDA’s enforcement report. The agency classified it as Class II on Oct. 19, indicating that exposure could cause temporary or medically reversible health effects.
The recall covers toothpaste sold under the Brush Buddies, Evo and ARU brands and distributed nationwide in the United States by Ashtel Studios Inc., based in Ontario, California. The affected products include children’s toothpastes featuring popular characters and flavors, along with adult formulas marketed for whitening, sensitivity, gum health and cavity protection.
The FDA’s enforcement report lists 4,301,700 tubes across the affected products. The agency cited deviations from current good manufacturing practices, which establish standards for manufacturing and testing products to help ensure their quality and safety.
The FDA’s definition of a Class II recall describes products whose use or exposure “may cause temporary or medically reversible adverse health consequences” or for which serious consequences are considered unlikely.
Check brush buddies, EVO and ARU products
The recalled Brush Buddies products include Barbie bubble gum, Hot Wheels strawberry, Crayola Silly Scents bubble gum, watermelon and strawberry, and My Little Pony bubble gum toothpastes. Several ice cream-inspired varieties are also affected, including vanilla, chocolate, mint chocolate chip and cookies ‘n cream.
Other recalled Brush Buddies products include whitening and cavity-protection formulas in peppermint and cool mint varieties. The evo range includes Advanced Whitening Anticavity Fluoride Toothpaste in peppermint and Sensitive Anticavity Fluoride Toothpaste in sweet mint.
Two ARU products are also included: toothpaste marketed for gum health in soothing mint and a cavity-protection formula in cool mint.
The affected products come in different package sizes, and the recall applies to specific product identifiers, lot codes and expiration dates. Consumers should consult the FDA’s official enforcement report rather than relying on a brand name or flavor alone to determine whether a tube is affected.
The listed expiration dates range from November 2026 through June 2028. The FDA’s records provide product-specific details, including identification numbers and affected lots, to help consumers check their toothpaste.
FDA assigns class II risk classification
A Class II designation means the FDA considers temporary or medically reversible health effects possible, while the probability of serious adverse health consequences is remote. It does not mean that every affected tube will cause harm.
The agency’s available recall information identifies manufacturing-practice deviations as the reason for the action but does not specify the precise defect. USA TODAY reported that it contacted the FDA for further details, but the agency did not immediately respond.
Consumers who find a potentially affected product should stop using it until they verify its status and follow any instructions issued by the manufacturer or the FDA. They should check the official recall listing for applicable lot numbers and expiration dates and contact the retailer or manufacturer for information about returns or refunds.
The recall highlights the importance of checking product notices even for everyday household items. Parents and caregivers should pay particular attention to children’s toothpaste featuring familiar characters, while adults should check whitening, sensitivity and gum-care products from the affected brands.
