Reported Jan 14, 2026 · Ongoing

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski,…

AvKARE

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AvKARE · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton
  • Manufactured forAvKARE, Pulaski, TN 38478
  • NDC50268-709-15
Lot codes and dates
    • Lot #49124
    • Exp Date 12/31/2026
Amount recalled
7,991 5x10 cartons

Where it was sold

  • Nationwide

Why it was recalled

Out of specification for dissolution.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:08 PM UTC

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