Irbesartan Tablets — Class II drug recall D-1294-2022
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2022-08-03, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1294-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2022-07-18 |
| Classified | 2022-07-26 |
| Reported by FDA | 2022-08-03 |
| Terminated | 2022-11-22 |
| Distributed | Nationwide (US) |
| Quantity | 28,560 bottles |
| Reason classes | specification failure |
| NDC | 59746-0447, 59746-0447-05, 59746-0447-30, 59746-0447-90, 59746-0448, 59746-0448-05, 59746-0448-30, 59746-0448-90, 59746-0449, 59746-0449-05, 59746-0449-30, 59746-0449-90 |
| Lot numbers | IB120012A, IB120013A, IB120014A |
| Expiration dates | 2022-08 |
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 for recall
Failed Dissolution Specifications
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-1294-2022. 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.