Recall: D-0292-2026

Class II - Potentially Harmful

Class IIClassification
2025-12-31Initiated
OngoingStatus
AvKAREFirm

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.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.