FDA Drugs recall ·
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle… recall
- Recall number
- D-0203-2025
- Date
- (initiated December 23, 2024)
- Company / brand
- Viatris Inc
1000 Mylan Blvd, Canonsburg, PA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 1,215/30 count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 8181625, Exp 12/31/2025
Distribution
USA nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0203-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.