Lamotrigine Tablets — Class III drug recall D-1289-2020
Terminated recall by AVKARE Inc., reported 2020-06-10, distributed nationwide. Presence of Foreign Substance consistent with granules from desiccant packs used during storage
| Recall number | D-1289-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2020-05-28 |
| Classified | 2020-06-04 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 4,124 bottles |
| NDC | 42291-0366, 42291-0366-01, 42291-0366-10, 42291-0367, 42291-0367-01, 42291-0367-10, 42291-0368, 42291-0368-50, 42291-0368-60, 42291-0369, 42291-0369-50, 42291-0369-60 |
| Expiration dates | 2021-09-30 |
Product
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Reason for recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
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-1289-2020. 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.