The Food and Drug Administration (FDA) classified a recall initiated by Pritam International Private Limited as Class II, covering 4,301,700 toothpaste tubes across 17 products, including children’s varieties.
Pritam began the recall Sept. 10, and the FDA assigned the classification Oct. 19. The agency’s enforcement record names Ashtel Studios Inc. as the distributor and lists the affected products and lot codes.
The listed items include selected Brush Buddies toothpaste featuring Barbie, Hot Wheels, Crayola Silly Scents and My Little Pony branding, as well as ice cream-flavored varieties. The products also include whitening, sensitivity, cavity-protection and gum-health toothpastes sold under Brush Buddies, evo, ARU and BB names.
The FDA gives the reason as deviations from current good manufacturing practice. Its record does not identify the specific deviation, an ingredient concern or another particular product defect.
The FDA’s general Class II definition covers products that may cause health effects that are temporary or medically reversible, as well as cases in which serious consequences are considered unlikely. This describes the agency’s recall category; the record does not provide a product-specific explanation of the risk.
The FDA says monitored recalls may appear in its enforcement report before or after classification, and companies may begin voluntary recalls and issue public notices earlier. Pritam’s Sept. 10 start date preceded the FDA’s classification by more than a month.
Consumers can compare a tube’s product details and lot code with the affected entries in the FDA enforcement record.
