Warning
AvKARE Recalls Rosuvastatin Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0292-2026Drug / Pharmaceutical
AvKARE Recalls Rosuvastatin Tablets
AvKARE · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from AvKARE, initiated on December 31, 2025. Out of specification for dissolution. This recall covers 7,991 5x10 cartons, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.