Class II · ModerateRecall completed
Irbesartan
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022
Where it was soldProduct was distributed to major distributors who may have further distributed the product nationwide.
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
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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 byLupin Pharmaceuticals, Inc.
| Brand name | IRBESARTAN |
| Generic name | IRBESARTAN |
| Active ingredient(s) | IRBESARTAN |
| Distributed by / for | Lupin Pharmaceuticals Inc. |
| NDC | 68180-411-06 |
Show the full FDA record
| Full product label | Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Distribution | Product was distributed to major distributors who may have further distributed the product nationwide. |
| Quantity | 134,016 bottles |
| Recall initiated | 2021-10-12 |
| Report date | 2021-11-10 |
| Recall completed | 2023-01-30 |
| Recall number | D-0087-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Baltimore 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.