Rosuvastatin Tablets recall (AvKARE)
DrugClass IIOngoing
Summary: AvKARE is recalling 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.
What is being recalled
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
Why
Out of specification for dissolution.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot #49124, Exp Date 12/31/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0292-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 31, 2025 |
| Reported | January 14, 2026 |
| Company | AvKARE |
| Company location | Pulaski, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7,991 5x10 cartons |
More recalls from AvKARE · all drug recalls · recalls from December 2025