Check your bathroom shelf: more than 4.3 million tubes of toothpaste sold across the United States are under a nationwide recall that the U.S. Food and Drug Administration classified on October 19 as Class II, according to the FDA's weekly enforcement report.

Source: The Healthy (FDA Enforcement Report)

India-based Pritam International Private Limited initiated the voluntary recall on September 10. The FDA later classified it Class II, a category used when using a product may cause temporary or medically reversible health problems, while the probability of serious harm is remote.

Which products are affected

The recall covers 17 products distributed by Ashtel Studios Inc. of Ontario, California, and sold under the Brush Buddies, evo and ARU brands through major retailers and online marketplaces including Amazon and eBay, CBS12 reported. Many are children's character pastes, including Brush Buddies Barbie, Hot Wheels, Crayola Silly Scents and My Little Pony lines, alongside adult whitening, sensitivity and gum-health formulas.

Federal records put the total at about 4,298,900 tubes, including more than 400,000 tubes each of the Barbie bubble-gum and Hot Wheels strawberry children's pastes.

Source: CBS12 via STL30

Why the recall was ordered

The FDA cited deviations from Current Good Manufacturing Practice (CGMP) regulations, the federal rules meant to guarantee a drug product's identity, strength, quality and purity. Because fluoride toothpaste is regulated as an over-the-counter drug, it must meet those standards. The FDA report did not specify the exact manufacturing failures behind the recall.

Consumers who bought the affected tubes should check the lot numbers and expiration dates listed in the FDA enforcement report against the packaging at home. Retailers have been notified, and the recall remains in progress.