Why it was recalled
Out of Specification for Dissolution
Product description
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Lot numbers, UPCs & expiration codes
Lot 45279, Exp 03/31/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0224-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 21, 2025
- FDA report date
- Feb 19, 2025
- Quantity
- 341 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0224-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96172
- Address
- 615 N 1st St
- Code information
- Lot 45279, Exp 03/31/2025
- Postal code
- 38478-2403
- Report date
- Feb 19, 2025
- Product type
- Drugs
- Recall number
- D-0224-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 341 cartons
- Reason for recall
- Out of Specification for Dissolution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2025