In the agency's Nov 11, 2026 enforcement report · Ongoing

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 50 Tablets (5 x 10) Unit Dose AVPAK, Manufactured for: AvKARE,…

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?

  • Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 50 Tablets (5 x 10) Unit Dose AVPAK
  • Manufactured forAvKARE, Pulaski, TN 38748, NDC 50268-330-15
Lot codes and dates
    • Lot # 48353
    • Exp. 10/31/2026
Amount recalled
8866 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

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 (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Nov 3, 11:26 PM UTC

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