FDA lists voluntary recall of more than 4.3 million toothpaste tubes over manufacturing-practice deviations

The US Food and Drug Administration has listed a voluntary recall of more than 4.3 million tubes of toothpaste in its enforcement report, classifying it Class II on 19 October.

The recall, initiated on 10 September, covers 17 toothpaste products totalling 4,301,700 tubes, made by Pritam International Private Limited of India and distributed by Ashtel Studios of Ontario, California. The stated reason is deviations from current good manufacturing practice (CGMP). The agency has not described the specific deviations, and has alleged no contamination.

Class II is the FDA’s middle tier: the agency’s definition says use of the products may cause temporary health problems, but that the likelihood of serious health consequences is remote. The classification does not itself identify what went wrong in manufacturing.

Affected lines include Brush Buddies Barbie Anticavity (Bubble Gum, 409,800 tubes), Hot Wheels (Strawberry, 411,600), three Crayola Silly Scents varieties (320,232 tubes each), My Little Pony (17,400), Evo Advanced Whitening (Peppermint, 405,336) and Evo Sensitive (Sweet Mint, 389,880), alongside ice-cream-flavoured varieties at 112,092 tubes each. The recall covers lots beginning LWP under NDC numbers beginning 84140; product labels carry “MADE IN INDIA” and the Ashtel Studios distribution line. No refund or replacement process had been set out as of 20 October.

Sources

• The Healthy, “Toothpaste Recall: Over 4 Million Tubes Recalled Nationwide” — https://www.thehealthy.com/news/toothpaste-recall-october-2026/
• global1.news, “4.3 Million Toothpaste Tubes Recalled Over CGMP Deviations” — https://global1.news/toothpaste-recall-4-3-million-tubes-fda-cgmp-deviations