PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 14, 2026 Initiated: December 31, 2025 #D-0292-2026

Product Description

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.

Details

Recalling Firm
AvKARE
Units Affected
7,991 5x10 cartons
Distribution
Nationwide in the USA
Location
Pulaski, TN

Frequently Asked Questions

What product was 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. Recalled by AvKARE. Units affected: 7,991 5x10 cartons.
Why was this product recalled?
Out of specification for dissolution.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 14, 2026. Severity: Moderate. Recall number: D-0292-2026.