D-0204-2025 Class II Terminated
FDA drug recall D-0204-2025 was initiated by Viatris Inc on Dec 23, 2024 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. The recall status is terminated (terminated Nov 12, 2025). Affected quantity: 6,605/30 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 22, 2025
- Initiation Date
- Dec 23, 2024
- Termination Date
- Nov 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,605/30 count bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Distribution Pattern
USA nationwide.
Code Information
Lot# 8182298, Exp 10/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0204-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026