Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured...
FDA Recall #D-0292-2026 — Class II — December 31, 2025
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.
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,991 5x10 cartons
Distribution
Nationwide in the USA
Code Information
Lot #49124, Exp Date 12/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated