FDA Drug recall D-0201-2025
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by:…
- FDA Drug
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by:… by Amerisource Health Services, citing presence of Foreign Tablets/Capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0201-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-07 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Reason
Presence of Foreign Tablets/Capsules
Identifiers
| ndc | 60687-423-11 |
|---|---|
| ndc | 60687-423-21 |
| code_info | Lot #: 1018598, Exp. Date 10/31/2025 |
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-0201-2025%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.