FDA Classifies Recall of 4.3 Million Fluoride Toothpaste Tubes as Class II

Edited by Dentaltown staff

The Food and Drug Administration has classified as Class II a voluntary recall of 4,301,700 tubes of fluoride toothpaste sold nationwide under the Brush Buddies, BB, evo, and ARU brands. The agency lists the reason as deviations from current good manufacturing practice.

India-based manufacturer Pritam International Private Limited initiated the recall Sept. 10, and the FDA classified it Oct. 19. Ashtel Studios Inc. of Ontario, California, distributed the products. The FDA lists the recall as ongoing.

The recall covers 17 products. Eleven are Brush Buddies toothpastes: three Crayola Silly Scents flavors; Hot Wheels, My Little Pony, and Barbie versions; four ice cream–flavored varieties; and a whitening toothpaste with baking soda. The other six are two BB (Brush Buddies) toothpastes, one for whitening and one for cavity protection; evo Sensitive and evo Advanced Whitening; and ARU Cavity Protection and ARU Gum Health.

Most of the products list sodium fluoride at 0.24% or 0.243% as the active ingredient. Two use sodium monofluorophosphate 0.76%, ARU Gum Health uses stannous fluoride 0.45%, and evo Sensitive pairs sodium fluoride with 5% potassium nitrate. The products came in 3.5-ounce and 4-ounce tubes and a two-tube value pack.

Individual product quantities ranged from 15,264 tubes to 797,868 tubes, the largest being Brush Buddies Whitening Anti-cavity Fluoride Toothpaste with Baking Soda in Cool Mint. The recall applies to specific lots of each product.

The FDA record does not describe the specific manufacturing problems behind the recall. The agency defines a Class II recall as one in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The FDA record lists the recall as voluntary and firm-initiated and notes that no press release was issued.

Sources:
U.S. Food and Drug Administration, Enforcement Report, Event 99849, Recall D-0065-2027, classified Oct. 19, 2026: accessdata.fda.gov/ires/Product=222779
U.S. Food and Drug Administration, “Recalls Background and Definitions”: fda.gov/recalls-background-and-definitions