FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Cardura

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# 8182298, Exp 10/31/2025
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byViatris Specialty LLC
Brand nameCARDURA
Generic nameDOXAZOSIN MESYLATE
Active ingredient(s)DOXAZOSIN MESYLATE
Distributed by / forViatris Specialty LLC, Morgantown, WV 26505
NDC58151-078-93
Show the full FDA record
Full product labelCardura 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 firmViatris Inc
DistributionUSA nationwide.
Quantity6,605/30 count bottles
Recall initiated2024-12-23
Report date2025-01-22
Recall completed2025-11-12
Recall numberD-0204-2025
ClassificationClass II
FDA statusTerminated
Origin on fileCanonsburg PA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.