FDAClass IIJuly 24, 2024

Cardura XL recall: Impurity Out of Spec

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

Why was Cardura XL recalled?

Failed Impurities/Degradation Specifications

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#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025

Product
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Recalling firm
Viatris Inc
Quantity
3,694 bottles
Distribution
U.S. Nationwide
Recall date
July 24, 2024
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls