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Drug FDA Class II Terminated Failed specifications

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

Viatris Inc Published Jan 22, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Viatris Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Impurity Compound B · primary

Affected products (1)

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

CARDURA · 6,605/30 count bottles

NDC: 58151-078, 58151-079, 58151-078-93, 58151-079-93
Lot codes: 8182298
Code info: Lot# 8182298, Exp 10/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 23, 2024
  2. Published
    Jan 22, 2025
  3. Terminated
    Nov 12, 2025
Recall number
D-0204-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.