FDA Drug recall D-0678-2026
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.)
- FDA Drug
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.) by Bell Pharmaceuticals, citing subPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0678-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-25 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bell Pharmaceuticals |
| Distribution | US |
Product
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
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Identifiers
| ndc | 51316-822-00 |
|---|---|
| ndc | 51316-823-00 |
| code_info | Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, e…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0678-2026%22
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