← FDA ENFORCEMENT
D-0203-2025Class II

Viatris Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 & Qualification
Reason 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

Data: U.S. FDA. 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. Open the enforcement explorer →