FDA Drug recall D-66014-001
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by…
- FDA Drug
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by… by Amneal Pharmaceuticals, citing failed dissolution specifications; 18 month CRT.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66014-001 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-17 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | IL, NH, NJ, NY, OH, RI, TN |
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
Failed dissolution specifications; 18 month CRT
Identifiers
| ndc | 65162-212-03 |
|---|---|
| ndc | 65162-212-10 |
| ndc | 65162-212-50 |
| ndc | 65162-212-11 |
| code_info | Batch/Lot HL50611, exp. 1/2014 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66014-001%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.