D-0681-2026 Class II Ongoing
FDA drug recall D-0681-2026 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: 16,156 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
- 16,156 units
Product Description
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
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) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.