AvKARE recalls Rosuvastatin Tablets
- Recalling company
- AvKARE
- Product
- Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
- Reason
- Out of specification for dissolution.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 31, 2025
- Reported
- Jan 14, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 7,991 5x10 cartons
- Lot / codes
- Lot #49124, Exp Date 12/31/2026
- Company location
- Pulaski, TN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0292-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0292-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.