D-0685-2026 Class II Ongoing
FDA drug recall D-0685-2026 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: 5, 471 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
- 5, 471 units
Product Description
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
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) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.