Reported Feb 19, 2025 · Ongoing

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478.…

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?

    • Irbesartan Tablets USP
    • 300 mg
    • 50 Tablets (5 x 10) Unit Dose per carton
  • Manufactured forAvKARE, Pulaski, TN 38478. NDC 50268-442-15
Lot codes and dates
    • Lot 45279
    • Exp 03/31/2025
Amount recalled
341 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, 8:09 PM UTC

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