FDA Drug recall D-0679-2026
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL)
- FDA Drug
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL) 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-0679-2026 |
| 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
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
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Identifiers
| ndc | 68229-102-01 |
|---|---|
| ndc | 68229-102-03 |
| ndc | 68229-102-02 |
| code_info | Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03. |
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-0679-2026%22
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