D-0679-2026 Class II Ongoing
FDA drug recall D-0679-2026 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: 29, 474 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
- 29, 474 units
Product Description
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
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) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.