FDA Drug recall D-0876-2023
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater…
- FDA Drug
- Class II
- terminated
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater… by Amneal Pharmaceuticals, citing failed Dissolution Specifications: Out-of-specification results for dissolution (above specification).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0876-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-05-30 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | LA, OH, PA |
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Reason
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Identifiers
| ndc | 65162-212-03 |
|---|---|
| ndc | 65162-212-10 |
| ndc | 65162-212-50 |
| ndc | 65162-212-11 |
| code_info | Lot # HL00721A, Exp. 12/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0876-2023%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.