The alpha blocker is typically prescribed to manage a nuisance symptom. Here's why the FDA says patients and healthcare professionals should check their supply.
Nearly 8,000 Bottles of a Prostate Prescription Have Been Recalled Nationwide
Published on Jan. 17, 2025
Prostate issues can trigger self-consciousness, but they’re overwhelmingly relatable—regarding enlarged prostate alone, Harvard Medical School has reported: “By age 60, half of all men will have an enlarged prostate, a condition also known as benign prostatic hyperplasia, or BPH. By age 85, the proportion reaches 90%.”
If you take medication to manage related symptoms, it’s worth being aware of a drug recall. On Thursday, Jan. 16, the U.S. Food and Drug Administration (FDA) announced a voluntary recall for 7,820 bottles of Cardura XL, known also as doxazosin (extended release), which is available by prescription only. The drug is known as an alpha blocker, often prescribed to help with urination difficulties associated with enlarged prostate (benign prostatic hyperplasia) symptoms, according to the Cleveland Clinic. (The non-extended release version of Cardura is also at times prescribed to treat high blood pressure.)
The reason for the Cardura XL recall notice appears to be issues that arose during stability tests, resulting in “failed impurities/degradation specifications” and “out of specification results.” The FDA has categorized the event as a Class II recall: “A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
In light of several recent and important blood pressure and pain & fever reliever medication recalls, consumers can confirm whether their prescriptions are affected by checking for the following details:
Cardura XL (doxazosin) extended release tablets, 8 mg
- 30-count bottles
- Lot # 8181625
- Expiration date: 12/31/2025
Cardura XL (doxazosin) extended release tablets, 4 mg
- 30-count bottles
- Lot # 8182298
- Expiration date: 10/31/2025
The distributor is listed as Viatris Speciality LLC in Morgantown, West Virginia, and the FDA’s notice says the recall affects pharmacies that have carried Cardura “USA Nationwide.”
If you have questions regarding your Cardura XL prescription, contact your pharmacist or primary care physician. To report an adverse reaction, you can fill out the FDA’s MedWatch Adverse Event Reporting program.
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