FDA Drug recall D-0688-2026
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785
- FDA Drug
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785 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-0688-2026 |
| 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
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Identifiers
| ndc | 72476-838-34 |
|---|---|
| code_info | Lot:1505141, 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-0688-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.