Prostate Medication Recalled

Viatris Inc. is recalling more than 16 000 bottles of Cardura XL (doxazosin) extended-release tablets for failing to meet impurity/degradation specifications, according to the July 24, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were made in Singapore and distributed throughout the United States by the Roerig division of Pfizer Inc., New York, New York:

• Cardura XL (doxazosin) extended-release tablets, 8 mg, in 30-count bottles (NDC 0049-2080-10), from lots 8147041 (Exp. 6/24) and 8163765 (Exp. 3/25); and
• Cardura XL (doxazosin) extended-release tablets, 4 mg, in 30-count bottles (NDC 0049-2040-10), from lots 8147040 (Exp. 6/24) and 8163764 (Exp. 3/25).

Viatris voluntarily initiated the recall on April 30, 2024. The FDA designated the recall Class II on July 16, 2024. Per the classification, use of the recalled tablets could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Cardura XL is a prescription drug used to treat urinary symptoms caused by benign prostatic hyperplasia.