Though most men would rather do just about anything besides talk about their prostate health—including seeing their favorite team lose—by the age of 60, half of men will have developed an enlarged prostate, also known as benign prostatic hyperplasia, according to Harvard Health Publishing. By age 85, that number climbs to a shocking 90%.

Given how many men suffer in silence, it’s a key conversation to have—not least because medication can help relieve the symptoms of enlarged prostate, which can include frequent urination, difficulty beginning to urinate, painful urination, urinary incontinence, and an inability to fully empty the bladder. 

However, a recently updated report from the U.S. Food and Drug Administration (FDA) implicating Cardura XL (Doxazosin) Extended Release Tablets, a common first-line treatment for enlarged prostate, serves as a reminder that even effective interventions still require some vigilance. More than 7,800 bottles of the prescription drug were recalled after the health authority discovered “impurities.” Specifically, the FDA says the recall went into effect due to “Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.”

Product details included:

Cardura XL (Doxazosin) Extended Release Tablets, 8 mg 

  • Lot Number: 8181625
  • Expiration Date: 12/31/2025

Cardura XL (Doxazosin) Extended Release Tablets, 4 mg

  • Lot Number: 8182298
  • Expiration Date: 10/31/2025

The affected drugs, produced by Viatris, Inc., were distributed nationwide in 30-count bottles of 8-milligram and 4-milligram doses. The recall—initially announced in December 2024—has now been terminated on November 12 after nearly a year, but consumers should still exercise caution given that one of the expiration dates has yet to pass.

In January 2025, the incident was marked as a Class II event, suggesting that taking the prostate drugs could cause “medically reversible adverse health consequences,” but that “the probability of serious adverse health consequences is remote.”

According to the healthcare company Kaiser Permanente, Cardura XL (Doxazosin) is an alpha blocker that reduces symptoms by relaxing the muscles in the prostate, a walnut-sized gland located below the bladder. In particular, it can alleviate difficulty urinating, weak stream, and frequent urination—including at night.

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