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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

IVAX Pharmaceuticals: Dissolution Failure; 18 month timepoint (stability)

Agency Publication Date: March 22, 2003
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Summary

IVAX Pharmaceuticals is recalling approximately 50 bottles of Terazosin Hydrochloride Capsules (1 mg) because the medication failed to meet dissolution standards during stability testing at the 18-month mark. Terazosin Hydrochloride is a prescription medication used to treat symptoms of an enlarged prostate and high blood pressure. When a drug fails dissolution testing, it may not break down and release into the bloodstream as intended, which can lead to reduced effectiveness or inconsistent treatment of the underlying condition. Consumers currently taking this medication should contact their healthcare provider or pharmacist for guidance.

Risk

The capsules may not dissolve properly in the body, which can prevent the active medication from being absorbed correctly and potentially lead to poorly controlled blood pressure or urinary symptoms.

What You Should Do

  1. Check your medication bottle to see if you have Terazosin Hydrochloride Capsules (1 mg) in 500-count bottles with NDC 0172-4336-70.
  2. Identify if your bottle was manufactured by Zenith Goldline Pharmaceuticals, Inc. or distributed by IVAX Pharmaceuticals.
  3. Contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and to obtain a replacement prescription if necessary.
  4. Return any unused portions of the affected medication to the pharmacy where it was purchased for a refund.
  5. For further questions regarding this recall, contact IVAX Pharmaceuticals at their Miami office or the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Terazosin Hydrochloride Capsules, 1 mg (500 count bottles)
Model:
NDC 0172-4336-70

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 25578
Status: Active
Manufacturer: IVAX Pharmaceuticals
Manufactured In: United States
Units Affected: 50 bottles

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.