D-0678-2026 Class II Ongoing
FDA drug recall D-0678-2026 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: 106,301 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
- 106,301 units
Product Description
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
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) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.