AvKARE recalls rosuvastatin 10 mg tablets because they failed a dissolution standard
AvKARE's rosuvastatin 10 mg tablets in 50-tablet unit dose cartons (7,991 cartons, sold nationwide) were out of specification for dissolution, meaning they did not meet the required standard.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- AvKARE
- Hazard
- Out of specification for dissolution.
- Units
- 7,991 5x10 cartons
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- January 20, 2026
- Recall started
- December 31, 2025
- FDA enforcement report
- January 14, 2026
- Identifiers
- Codes: Lot #49124, Exp Date 12/31/2026
- FDA recall number: D-0292-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Out of specification for dissolution.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 7,991 5x10 cartons
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