FDAFDA · Food and drugs·Recall number D-0224-2025
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Published February 19, 2025 · Recall initiated: January 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of Specification for Dissolution
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IRBESARTAN
- Manufacturer
- AvKARE
- Distributor
- Nationwide in the USA
- Lot
- Lot 45279, Exp 03/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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