Extended Phenytoin Sodium Capsules — Class II drug recall D-0876-2023
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2023-06-21, distributed in LA, OH, PA. Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
| Recall number | D-0876-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2023-05-30 |
| Classified | 2023-06-15 |
| Reported by FDA | 2023-06-21 |
| Terminated | 2025-06-10 |
| Distributed | LA, OH, PA |
| Quantity | 9,056 bottles |
| Reason classes | specification failure |
| NDC | 65162-0212, 65162-0212-03, 65162-0212-10, 65162-0212-11, 65162-0212-50 |
| Lot numbers | HL00721A |
| Expiration dates | 2023-12 |
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 for recall
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0876-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.