Full Breakdown
Nationwide Recall of Branded Kids' Toothpaste
By Drooid · · How we work
Core Event: FDA Issues Class II Recall of Over 4 Million Tubes
The U.S. Food and Drug Administration (FDA) has ordered a nationwide recall of more than 4 million tubes of children’s toothpaste sold under the Brush Buddies, Evo and ARU brands. The recall, announced in early September, remains active. Products featuring Barbie, Hot Wheels and Crayola branding are included.
Background & Context: Recall Classification and Health Risks
The FDA classified the action as a Class II recall, indicating that the manufacturing deviations could cause temporary or medically reversible adverse health consequences, while serious health effects are considered unlikely. The agency’s classification reflects violations of current good manufacturing practice (CGMP) requirements.
Data & Statistics: Scope of Affected Products
- Brush Buddies Barbie Bubble-Gum Flavor: ? 410,000 tubes
- Brush Buddies Hot Wheels Strawberry Flavor: ? 412,000 tubes
- Crayola Silly Scents (bubble-gum, watermelon, strawberry): ? 960,000 tubes total
- Brush Buddies Whitening Anti-Cavity Fluoride with Baking Soda (Cool Mint): ? 798,000 tubes
- Additional quantities include Evo Advanced Whitening, Evo Sensitive, and ARU Gum Health and Cavity Protection varieties.
The affected toothpaste was distributed by California-based Ashtel Studios Inc. and manufactured by Pritam International Private Limited in India.
Official Statements & Responses: FDA Guidance and Ongoing Actions
The FDA’s notice explains that exposure to the recalled toothpaste could lead to reversible health issues, but the likelihood of serious harm is remote. The agency advises consumers to stop using the products immediately and to return them to the point of purchase for a refund. The FDA’s website provides a complete list of recalled items and instructions for disposal.
What’s Next: Consumer Guidance and Ongoing Monitoring
Consumers should check the FDA’s online recall page to confirm whether a specific product is included. Retailers are expected to remove the affected tubes from shelves while the recall remains in effect. The FDA and the companies involved have not provided a timeline for when the recall will be completed.