D-0686-2026 Class II Ongoing

Recalled by Bell Pharmaceuticals, Inc — Belle Plaine, MN

FDA drug recall D-0686-2026 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: 31,094 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
31,094 units

Product Description

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

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:1505161, 1505181, 1505301, 1505382, exp 2027-04.