FDA Drug recall D-1294-2022
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd
- FDA Drug
- Class II
- terminated
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd by Jubilant Cadista Pharmaceuticals, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1294-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-18 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 59746-447-30 |
|---|---|
| ndc | 59746-447-90 |
| ndc | 59746-447-05 |
| ndc | 59746-448-30 |
| ndc | 59746-448-90 |
| ndc | 59746-448-05 |
| ndc | 59746-449-30 |
| ndc | 59746-449-90 |
| ndc | 59746-449-05 |
| code_info | Lot #: IB120012A, IB120013A, IB120014A Exp. date 08/2022 |
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-1294-2022%22
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