Recalls / Class II
Class IID-0204-2025
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
- Brand name
- Cardura
- Generic name
- Doxazosin Mesylate
- Active ingredient
- Doxazosin Mesylate
- Route
- Oral
- NDCs
- 58151-078, 58151-079
- FDA application
- NDA021269
- Affected lot / code info
- Lot# 8182298, Exp 10/31/2025
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Recalling firm
- Firm
- Viatris Inc
- Manufacturer
- Viatris Specialty LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 6,605/30 count bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-12-23
- FDA classified
- 2025-01-16
- Posted by FDA
- 2025-01-22
- Terminated
- 2025-11-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0204-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.