Extended Phenytoin Sodium Capsules — Class II drug recall D-66014-001
Terminated recall by Amneal Pharmaceuticals of New York, LLC., reported 2013-11-13, distributed in IL, NH, NJ, NY, OH, RI, TN. Failed dissolution specifications; 18 month CRT
| Recall number | D-66014-001 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC., Hauppauge, NY, United States |
| Recall initiated | 2013-08-17 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-07-17 |
| Distributed | IL, NH, NJ, NY, OH, RI, TN |
| Quantity | 895 |
| Reason classes | specification failure |
| NDC | 65162-0212, 65162-0212-03, 65162-0212-10, 65162-0212-11, 65162-0212-50 |
| Lot numbers | HL50611 |
| Expiration dates | 2014-01 |
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Reason for recall
Failed dissolution specifications; 18 month CRT
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-66014-001. 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.