Class IITerminated

Cardura XL (doxazosin) extended release tablets 4 mg recall

FDA recall D-0204-2025 · initiated Dec 23, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Details

Product: Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Recalling company: Viatris
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: USA nationwide.
Initiated: Dec 23, 2024
FDA report date: Jan 22, 2025

This recall is linked to a product we cover: Cardura XL →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0204-2025 ↗

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