Extended Phenytoin Sodium Capsules — Class II drug recall D-1246-2015
Terminated recall by Wockhardt Usa Inc., reported 2015-07-29, distributed nationwide. CGMP Deviations: Firm did not adequately investigate customer complaints.
| Recall number | D-1246-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2018-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 53,894 bottles |
| Reason classes | cgmp |
| NDC | 64679-0720-01, 64679-0720-02 |
| Lot numbers | DM11412, DM11488, DM11642, DM11682, DM12093, DM12094, DM12533, DM12540, DM12609, DM12898, DM12899, DN10163, DN10273, DN10487 |
| Expiration dates | 2015-04-30, 2015-05-31, 2015-06-30, 2015-07-31, 2015-09-30, 2015-11-30, 2015-12-31 |
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
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-1246-2015. 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.