UnratedDrug recall · FDA · Published April 30, 2024
Viatris Cardura XL 8mg Tablets Recall: Impurities May Cause Harm
Viatris recalls Cardura XL 8mg tablets made in Singapore with potential impurities. This recall affects specific lots of the prescription medication. Consumers should contact the manufacturer for details.
“Viatris Cardura XL 8mg Tablets Recall: Impurities May Cause Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32699-viatris-cardura-xl-8mg-tablets-recall-impurities-may-cause-harm. Based on FDA recall #D-0603-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0603-2024%22&limit=1).
Viatris Inc. voluntarily recalled Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles distributed by Roerig after the FDA announced the recall on April 30, 2024. The product failed impurity and degradation specifications.
The recall addresses failed impurities and degradation specifications in the medication.
Context
GovInfoNow's records show Viatris, Inc. has had 10 other recalls on record since April 28, 2022. Other recent recalls of similar products include Viatris Xanax XR 3mg Tablets Recall (March 17, 2026), Viatris Cardura XL 8mg Tablets Recall (December 23, 2024), and Viatris Levothyroxine Tablets Recall (November 18, 2024). Other recent recalls of similar products include Hikma Ramipril Capsules 10mg Recall (August 24, 2026), Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026), and Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (June 1, 2026).
How to tell if you have this one
Check the product label for the lot number: 8147041 (expires June 2024) or 8163765 (expires March 2025). The product is a prescription medication made in Singapore by Viatris.
Brand
Viatris
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Completed
Distribution
U.S. Nationwide
Recall number
Product, codes & lots
Quantity
D-0602-2024
Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10; Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 2025
12,691 bottles
D-0603-2024
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; Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025
3,694 bottles
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number on the label: 8147041 (expiring June 2024) or 8163765 (expiring March 2025).
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0603-2024 (April 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0603-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.