Lamotrigine Tablets — Class III drug recall D-1281-2020
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2020-06-03, distributed in TN. Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs util
| Recall number | D-1281-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2020-05-26 |
| Classified | 2020-05-29 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-11-15 |
| Distributed | TN |
| Quantity | 1,313,333 tablets |
| NDC | 59746-0247-97 |
| Lot numbers | 19P0437, 19P0438 |
| Expiration dates | 2021-09-30 |
Product
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
Reason for recall
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
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-1281-2020. 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.