Recalling firm
Viatris Inc
Product type
Drug
Status
Terminated
Report date
2025-01-22
Distribution
USA nationwide.
Firm state
PA
Product quantity
1,215/30 count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
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
Code / lot info
Lot # 8181625, Exp 12/31/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.