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.

Recall Number: D-0688-2026

Firm: Bell Pharmaceuticals, Inc

Classification: Class II

Status: Ongoing

Report Date: 20260722

Initiation Date: 20260625

Termination Date:

Reason for Recall

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

Product Description

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.