More than 4 million tubes of toothpaste, including some popular kids’ brands, is being recalled nationwide.
A voluntary recall was initiated by Pritam International Private Limited on Sept. 10, according to an enforcement report from the U.S. Food and Drug Administration. The FDA classified the recall as Class II on Oct. 19.
A Class II recall represents the FDA’s second-most severe alert level, defined as “a situation in which 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 did not list a reason for the recall, but it is categorized as “CGMP Deviations,” meaning the manufacturer didn’t fully follow Current Good Manufacturing Practice requirements when making the product.
CGMP is a set of FDA regulations that govern how products are tested, made, packaged and stored.
Products on the recall list include:
Brush Buddies
- Brush Buddies Barbie Anticavity Fluoride Toothpaste, Bubble Gum (4.0 oz), D-0053-2027, NDC 84140-001-40, 409,800 tubes
- Brush Buddies Hot Wheels Anticavity Fluoride Toothpaste, Strawberry (4.0 oz), D-0054-2027, NDC 84140-002-40, 411,600 tubes
- Brush Buddies Crayola Silly Scents, Bubble Gum (4.0 oz), D-0055-2027, NDC 84140-003-40, 320,232 tubes
- Brush Buddies Crayola Silly Scents, Watermelon (4.0 oz), D-0056-2027, NDC 84140-004-40, 320,232 tubes
- Brush Buddies Crayola Silly Scents, Strawberry (4.0 oz), D-0057-2027, NDC 84140-005-40, 320,232 tubes
- Brush Buddies My Little Pony Scents, Bubble Gum (4.0 oz), D-0058-2027, NDC 84140-008-40, 17,400 tubes
- Brush Buddies Vanilla Ice Cream Flavored (3.5 oz), D-0061-2027, NDC 84140-517-35, 112,092 tubes
- Brush Buddies Mint Chocolate Chip Ice Cream Flavored (3.5 oz), D-0062-2027, NDC 84140-520-35, 112,092 tubes
- Brush Buddies Cookies ‘n Cream Ice Cream Flavored (3.5 oz), D-0063-2027, NDC 84140-519-35, 112,092 tubes
- Brush Buddies Chocolate Ice Cream Flavored (3.5 oz), D-0064-2027, NDC 84140-518-35, 112,092 tubes
- Brush Buddies Whitening with Baking Soda, Cool Mint (3.5 oz), D-0065-2027, NDC 84140-007-07, 797,868 tubes
Evo toothpaste
- evo Advanced Whitening, Peppermint (3.5 oz), D-0059-2027, NDC 84140-886-19, 405,336 tubes
- evo Sensitive, Sweet Mint (3.5 oz), D-0060-2027, NDC 84140-620-35, 389,880 tubes
BB toothpaste
- BB Cavity Protection, Cool Mint, 2 Value Pack (two 3.5 oz tubes), D-0066-2027, NDC 84140-035-10, 231,936 tubes
- BB Advanced Whitening, Peppermint (3.5 oz), D-0067-2027, NDC 84140-885-42, 198,288 tubes
ARU toothpaste
- ARU Gum Health, Soothing Mint (3.5 oz), D-0068-2027, NDC 84140-786-35, 15,264 tubes
- ARU Cavity Protection, Cool Mint (3.5 oz), D-0069-2027, NDC 84140-785-35, 15,264 tubes
For more on the recall, click here
