Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Product description
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Lot numbers, UPCs & expiration codes
Lot # 8181625, Exp 12/31/2025
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0203-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2024
- FDA report date
- Jan 22, 2025
- Quantity
- 1,215/30 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0203-2025, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 96036
- Address
- 1000 Mylan Blvd
- Code information
- Lot # 8181625, Exp 12/31/2025
- Postal code
- 15317-5853
- Report date
- Jan 22, 2025
- Product type
- Drugs
- Recall number
- D-0203-2025
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 1,215/30 count bottles
- Termination date
- Nov 12, 2025
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Dec 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2025