Class II · ModerateActive recall
Irbesartan
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot 45279, Exp 03/31/2025
Where it was soldNationwide in the USA
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
Out of Specification for Dissolution
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 byAvPAK
| Brand name | IRBESARTAN |
| Generic name | IRBESARTAN |
| Active ingredient(s) | IRBESARTAN |
| Distributed by / for | AvKARE, Pulaski, TN 38478 |
| NDC | 50268-442-15 |
Show the full FDA record
| Full product label | Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 |
| Recalling firm | AvKARE |
| Distribution | Nationwide in the USA |
| Quantity | 341 cartons |
| Recall initiated | 2025-01-21 |
| Report date | 2025-02-19 |
| Recall completed | — |
| Recall number | D-0224-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pulaski TN 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.