FDA Drug recall D-1281-2020
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801,…
- FDA Drug
- Class III
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class III recall of Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801,… by Jubilant Cadista Pharmaceuticals, citing presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1281-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-26 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | TN |
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
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Identifiers
| code_info | Lot #s 19P0437 & 19P0438, Exp. 09/30/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1281-2020%22
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