Barbie, Hot Wheels and Crayola kids' toothpastes among 4 million tubes recalled nationwide

More than 4 million tubes of toothpaste, many of them flavored and branded for children, are being recalled nationwide, according to the U.S. Food and Drug Administration's enforcement report as reported by Fox Business and NBC New York. The recall covers more than a dozen products sold under the Brush Buddies, Evo and ARU brands.

What is covered

The largest single entries, per Fox Business:

• Crayola Silly Scents (bubble gum, watermelon and strawberry): more than 960,000 tubes combined.
• Brush Buddies Whitening Anti-Cavity Fluoride with Baking Soda, Cool Mint: nearly 798,000 tubes.
• Hot Wheels Strawberry: 411,600 tubes.
• Barbie Bubble Gum: 409,800 tubes.

The recall also takes in a My Little Pony flavor, several ice cream-flavored varieties, two Evo products (whitening and sensitivity) and two ARU products (cavity protection and gum health). NBC New York reports that more than half of the roughly 4 million tubes are the character-themed Brush Buddies pastes. Medical Daily puts the total at about 4.3 million tubes.

Who made it, and what the FDA said

The toothpaste was made by Pritam International Private Limited in India and distributed nationwide by Ashtel Studios Inc., both outlets report. The company began the recall on Sept. 10. NBC New York reports the FDA classified it Class II on Monday, Oct. 19.

The stated reason is "deviations" from current good manufacturing practice (CGMP), the rules on how a product is made, processed and packed. NBC New York says the FDA did not list which deviations sparked the recall and referred questions to the company. Fox Business said neither Pritam nor the FDA could immediately be reached for comment. That means the public record does not yet say whether the issue is contamination, strength or something else.

What Class II means

The FDA defines Class II as a situation where using or being exposed to a violative product "may cause temporary or medically reversible adverse health consequences," or where the probability of serious harm is remote. It is the agency's second-most severe level. It is not the level used for products expected to cause serious injury.

What parents can do

• Check the tube against the full product list, with lot codes and expiration dates, in the FDA's enforcement report. Fox Business and NBC New York both link to it. Brand names alone are not enough, because only listed lots are affected.
• If your tube matches, set it aside and check the retailer's return policy for a refund or exchange. We have not seen a company refund notice, so confirm with the store.
• If a child has had a reaction, call a pediatrician or Poison Control (1-800-222-1222).

The recall is ongoing, and the FDA can update the product list. We will update this story if the agency or the company says what the manufacturing problem was.

Sources: Fox Business; NBC New York; Medical Daily; FDA recalls. This is general information, not medical advice.