D-0688-2026 Class II Ongoing

Recalled by Bell Pharmaceuticals, Inc — Belle Plaine, MN

FDA drug recall D-0688-2026 was initiated by Bell Pharmaceuticals, Inc on June 25, 2026 and is designated Class II. Reason for recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). The recall status is ongoing. Affected quantity: 1,201 units.

Recall Details

Product Type
Drugs
Report Date
July 22, 2026
Initiation Date
June 25, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,201 units

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.

Reason for Recall

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

Distribution Pattern

U.S Nationwide

Code Information

Lot:1505141, exp 2027-04.