D-0684-2026 Class II Ongoing

Recalled by Bell Pharmaceuticals, Inc — Belle Plaine, MN

FDA drug recall D-0684-2026 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: 20, 160 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
20, 160 units

Product Description

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.

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: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04