Lamotrigine Extended-Release Tablets — Class II drug recall D-1245-2015
Terminated recall by Wockhardt Usa Inc., reported 2015-07-29, distributed nationwide. CGMP Deviations: Firm did not adequately investigate customer complaints.
| Recall number | D-1245-2015 |
|---|---|
| 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 | 5,910 bottles |
| Reason classes | cgmp |
| NDC | 64679-0271-01 |
| Lot numbers | DN10114 |
| Expiration dates | 2015-11-30 |
Product
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.
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-1245-2015. 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.