Lower riskDrug recall · FDA · Published December 23, 2024
Viatris Cardura XL 8mg Tablets Recall: Impurity Risk in Extended Release Form
Viatris recalls Cardura XL 8mg extended-release tablets due to impurity issues detected in stability testing. Affected lots may pose risks if stored improperly.
“Viatris Cardura XL 8mg Tablets Recall: Impurity Risk in Extended Release Form.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32345-viatris-cardura-xl-8mg-tablets-recall-impurity-risk-in-extended. Based on FDA recall #D-0203-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0203-2025%22&limit=1).
The FDA announced on 2024-12-23 that Viatris Inc. is recalling Cardura XL (doxazosin) extended release tablets due to failed impurity specifications. The recall affects 1,215 bottles of the 8 mg, 30-count product distributed nationwide.
The recall was initiated because out-of-specification results were observed for the impurity compound B during stability testing. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Viatris, Inc. has had 10 other recalls since 2022-04-28. Recent Viatris recalls include Xanax XR 3mg Tablets on 2026-03-17 for failed dissolution specifications and Levothyroxine Tablets on 2024-11-18 for potency failures. Other recent recalls of similar products include Ajanta Pharma Fluphenazine Tablets Recall (2026-08-25), Hikma Ramipril Capsules 10mg Recall (2026-08-24), and Glenmark Alyacen Birth Control Tablets Recall (2026-05-27).
How to tell if you have this one
Check for the lot number 8181625 on the bottle label. The product is a prescription-only 30-count bottle of Cardura XL 8mg extended-release tablets with an expiration date of December 31, 2025.
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.
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-0203-2025 (December 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0203-2025 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.