D-0683-2026 Class II Ongoing

Recalled by Bell Pharmaceuticals, Inc — Belle Plaine, MN

FDA drug recall D-0683-2026 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: 11, 977 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
11, 977 units

Product Description

FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.

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: 1505124, 1505311, 1505332, expires: 2027-04.