Lamotrigine Tablets — Class II drug recall D-66403-003
Terminated recall by Mylan Pharmaceuticals Inc., reported 2013-11-13, distributed nationwide. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured accord
| Recall number | D-66403-003 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2013-09-13 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 28,140 bottles |
| Reason classes | cgmp |
| NDC | 00378-4254-05, 00378-4254-91 |
Product
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason for recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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-66403-003. 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.