Viatris recalls Cardura XL 8mg extended-release tablets due to impurity issues detected in stability testing. Affected lots may pose risks if stored improperly.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris is recalling Cardura XL 8mg extended-release tablets because stability testing found impurities that could affect safety. This recall affects prescription-only bottles sold with specific lot numbers and expiration dates.
The stability testing showed impurity compound B levels outside acceptable limits. This could mean the tablets might not work as intended or could cause unexpected reactions if stored improperly.
Prescription holders of Cardura XL 8mg tablets with lot number 8181625 (expiring Dec 31, 2025) are affected. Patients using these tablets for blood pressure should check their lot numbers.
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.
Look for the lot number 8181625 on the bottle label to confirm if it's affected.
The stability testing found impurity compound B levels outside acceptable limits, which could affect the product's safety and effectiveness.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
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 expiring Dec 31, 2025.
We’ve drafted a message you can send Viatris to request your refund or repair — edit it as you like.
Subject: Recall D-0203-2025 — Viatris Viatris Hello, I own a Viatris that is covered by recall D-0203-2025 from Viatris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
