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.
Other recalls by Jubilant Cadista Pharmaceuticals
- Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 597…
FDA Drug · Class III · 2023-01-11 · Jubilant Cadista Pharmaceuticals - Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc
FDA Drug · Class III · 2022-04-13 · Jubilant Cadista Pharmaceuticals - Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadis…
FDA Drug · Class I · 2022-04-06 · Jubilant Cadista Pharmaceuticals
All Jubilant Cadista Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1281-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.