Lamotrigine Tablets — Class III drug recall D-1329-2022
Terminated recall by AVKARE Inc., reported 2022-08-17, distributed nationwide. Labeling: Label Error on Declared Strength
| Recall number | D-1329-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2022-07-20 |
| Classified | 2022-08-08 |
| Reported by FDA | 2022-08-17 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 8,328 bottles |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00342291367104 |
| 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 |
| Lot numbers | 37623, 38723, 41204, 42484, 42581 |
| Expiration dates | 2022-10, 2023-02, 2024-05, 2024-11, 2024-12 |
Product
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Reason for recall
Labeling: Label Error on Declared Strength
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-1329-2022. 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.