The U.S. Food and Drug Administration has classified a toothpaste recall involving 4.2 million tubes as a Class II event after the products were first withdrawn on Sept. 10. The recall covers dessert-flavored and toy-themed toothpaste sold on eBay and Amazon.
The scope is wide. It reaches Brush Buddies products tied to Barbie, Hot Wheels, Crayola Silly Scents, My Little Pony Scents Anticavity Fluoride Toothpaste, Vanilla Ice Cream Flavored Toothpaste, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Cookies 'n Cream Ice Cream Flavored Toothpaste and Chocolate Ice Cream Flavored Toothpaste, along with evo Advanced Whitening Anticavity Fluoride Toothpaste and evo Sensitive Anticavity Fluoride Toothpaste. It also includes Brush Buddies Whitening Anti-cavity Fluoride Toothpaste with Baking Soda, BB Cavity Protection Anti-Cavity Flouride Toothpaste, BB Advanced Whitening Anti-Cavity Fluoride Toothpaste, and ARU Toothpaste in Gum Health Soothing Mint and Cavity Protection 9 Ingredients Cool Mint.
The FDA says a Class II event means exposure to the product may cause temporary or medically reversible adverse health consequences. Darin Detwiler said cGMP regulations are baseline standards manufacturers are legally required to follow to ensure product quality, cleanliness, consistency and safety, and that deviations can compromise the integrity of the entire production process.
That is what gives this recall its edge. The classification leaves room for the idea that not every violation becomes an immediate health threat, but Detwiler said a recall of this size means the FDA and the company found enough of a potential risk, such as contamination or a quality failure, that it was not worth gambling with public safety. What the notice does not spell out is the exact trigger for the toothpaste recall, or what consumers should do next.
