Class II · ModerateRecall completed
Irbesartan
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: IB220023A, exp. date 08/2022
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed dissolution specifications.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byJubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA foreign manufacturer
| Brand name | IRBESARTAN |
| Generic name | IRBESARTAN |
| Active ingredient(s) | IRBESARTAN |
| Distributed by / for | Jubilant Cadista Pharmaceuticals, Inc. |
| NDC | 59746-448-90 |
Show the full FDA record
| Full product label | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 9,600 bottles |
| Recall initiated | 2022-07-18 |
| Report date | 2022-08-03 |
| Recall completed | 2022-11-22 |
| Recall number | D-1293-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Salisbury MD United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.