Medications & Supplements/Prescription Drugs

Cardura XL (doxazosin) Recalled for Impurity Specifications Failure

Agency Publication Date: January 16, 2025

Summary

Viatris Inc is recalling 7,820 bottles of Cardura XL (doxazosin) extended release tablets in both 4 mg and 8 mg strengths. The recall was issued after stability testing revealed that levels of an impurity called compound B were higher than the allowed safety specifications. Cardura XL is a prescription medication primarily used to treat high blood pressure and symptoms of an enlarged prostate.

Risk

Taking medication that has levels of impurities or degradation products exceeding approved limits may compromise the long-term safety and effectiveness of the drug. While no incidents have been reported, these impurities represent a failure to meet the manufacturer's quality standards.

What You Should Do

This recall affects Cardura XL (doxazosin) extended release tablets sold in 30-count bottles in 4 mg (NDC 58151-078-93) and 8 mg (NDC 58151-079-93) strengths.
To identify if your medication is affected, check the lot number and expiration date printed on the bottle. Affected 8 mg bottles have lot number 8181625 (Expiration 12/31/2025), and affected 4 mg bottles have lot number 8182298 (Expiration 10/31/2025).
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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) (8 mg)

Variants: 8 mg, Extended Release Tablet, 30-count bottle

Lot Numbers:

8181625 (Exp 12/31/2025)

NDC:

58151-079-93

Quantity: 1,215 bottles

Product: Cardura XL (doxazosin) (4 mg)

Variants: 4 mg, Extended Release Tablet, 30 -count bottle

Lot Numbers:

8182298 (Exp 10/31/2025)

NDC:

58151-078-93

Quantity: 6,605 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96036

Status: Resolved

Manufacturer: Viatris Inc

Sold By: Viatris Specialty LLC; Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2 products (1,215/30 count bottles; 6,605/30 count 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 · 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.

Summary

What You Should Do

This recall affects Cardura XL (doxazosin) extended release tablets sold in 30-count bottles in 4 mg (NDC 58151-078-93) and 8 mg (NDC 58151-079-93) strengths.

To identify if your medication is affected, check the lot number and expiration date printed on the bottle. Affected 8 mg bottles have lot number 8181625 (Expiration 12/31/2025), and affected 4 mg bottles have lot number 8182298 (Expiration 10/31/2025).

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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) (8 mg)

Variants: 8 mg, Extended Release Tablet, 30-count bottle

Lot Numbers:

8181625 (Exp 12/31/2025)

NDC:

58151-079-93

Quantity: 1,215 bottles

Product: Cardura XL (doxazosin) (4 mg)

Variants: 4 mg, Extended Release Tablet, 30 -count bottle

Lot Numbers:

8182298 (Exp 10/31/2025)

NDC:

58151-078-93

Quantity: 6,605 bottles