FDAClass IIJanuary 22, 2025

Cardura XL recall: Impurity Out of Spec

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 Cardura XL recalled?

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 8181625, Exp 12/31/2025

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
Recalling firm
Viatris Inc
Quantity
1,215/30 count bottles
Distribution
USA nationwide.
Recall date
January 22, 2025
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls