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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cardura XL (doxazosin) Recalled for Failed Impurity Specifications

Agency Publication Date: July 17, 2024
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Summary

Viatris Inc is recalling 16,385 bottles of Cardura XL (doxazosin) extended release tablets, a prescription medication used to treat high blood pressure and symptoms of an enlarged prostate. The recall was initiated because the tablets failed to meet required specifications for impurities and degradation. This means the medication may contain unintended substances that could compromise its quality or safety. To date, no injuries or incidents related to this issue have been reported.

Risk

Failed impurity and degradation specifications indicate that the chemical composition of the medication has changed or contains unintended byproducts. This poses a risk as it may reduce the effectiveness of the drug or expose the patient to unexpected substances, although the specific health impact depends on the nature of the impurity.

What You Should Do

  1. This recall affects Cardura XL (doxazosin) extended release tablets in 4mg and 8mg strengths, sold in 30-count bottles.
  2. Identify your medication by checking the National Drug Code (NDC) and lot numbers on the bottle label. Affected 4mg bottles have NDC 0049-2040-10 with lot numbers 8147040 (Exp. June 2024) or 8163764 (Exp. March 2025). Affected 8mg bottles have NDC 0049-2080-10 with lot numbers 8147041 (Exp. June 2024) or 8163765 (Exp. March 2025).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cardura XL (doxazosin) extended release tablets 4mg (30-count bottle)
Variants: 4mg strength, 30-count bottle, Rx Only
Lot Numbers:
8147040 (Exp. June 2024)
8163764 (Exp. March 2025)
NDC:
0049-2040-10

Distributed by Roerig Division of Pfizer Inc.

Product: Cardura XL (doxazosin) extended release tablets 8mg (30-count bottle)
Variants: 8mg strength, 30-count bottle, Rx Only
Lot Numbers:
8147041 (Exp. June 2024)
8163765 (Exp. March 2025)
NDC:
0049-2080-10

Distributed by Roerig Division of Pfizer Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94519
Status: Resolved
Manufacturer: Viatris Inc
Sold By: Pharmacies
Manufactured In: Singapore, United States
Units Affected: 2 products (12,691 bottles; 3,694 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.