Recalls / Class II
Class IID-0224-2025
Product
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
- Brand name
- Irbesartan
- Generic name
- Irbesartan
- Active ingredient
- Irbesartan
- Route
- Oral
- NDCs
- 50268-441, 50268-440, 50268-442
- FDA application
- ANDA202910
- Affected lot / code info
- Lot 45279, Exp 03/31/2025
Why it was recalled
Out of Specification for Dissolution
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 341 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-01-21
- FDA classified
- 2025-02-11
- Posted by FDA
- 2025-02-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0224-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.