Bell Pharmaceuticals, Inc: Careone, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 Ml), Bottle

Recall Summary CAREone Carbamide Peroxide 6.5% ear drops (0.5 FL OZ bottles) are being recalled nationwide because the product contains significantly less active ingredient than labeled—approximately 0.6% instead of 6-7%—and has an incorrect pH level that may reduce effectiveness. The product was distributed by Foodhold U.S.A, LLC across all U.S. states and Washington, D.C. This is classified as a Class II recall, meaning use of the product could cause temporary or reversible health effects.

Recalling firm

Bell Pharmaceuticals, Inc

Product

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

Reason

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-25

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/31942794-b8d3-40e9-92a9-a7470dca7a44