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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Pharmaceuticals USA Inc: Carvedilol Tablets Recalled Due to Foreign Tablet Contamination

Agency Publication Date: April 25, 2019
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Summary

Zydus Pharmaceuticals is recalling 7,668 bottles of Carvedilol (3.125 mg) after a customer discovered a fragmented, light yellow tablet of a different medication mixed in with their prescription. Carvedilol is commonly used to treat high blood pressure and heart failure. The presence of a foreign medication in your prescription bottle means you could accidentally ingest a drug you were not prescribed, which may lead to unexpected side effects or interactions with your current treatment. These products were distributed nationwide across the United States in 500-count bottles.

Risk

Ingesting a fragmented tablet of an unknown drug product can cause unpredictable pharmacological effects, allergic reactions, or dangerous drug-drug interactions. Because the foreign substance was identified as a fragment of another medication, consumers are at risk of taking a dose of a drug not intended for them.

What You Should Do

  1. Check your prescription bottle for Carvedilol Tablets, USP, 3.125 mg (500-count bottles) with NDC 68382-092-05.
  2. Verify if your bottle belongs to Lot Z803518 with an expiration date of 08/2020.
  3. If your bottle matches these details, stop using the medication immediately and inspect the tablets for any foreign or fragmented pieces that do not match the rest of the medication.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement supply of your medication.
  5. Return any unused product from the affected lot to your pharmacy for a refund and contact Zydus Pharmaceuticals for further instructions.
  6. For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider 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: Carvedilol Tablets, USP, 3.125 mg (500-count bottle)
Model:
NDC 68382-092-05
Lot Numbers:
Z803518 (Exp 08/2020)
Date Ranges: Expiration 08/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82682
Status: Resolved
Manufacturer: Zydus Pharmaceuticals USA Inc
Manufactured In: India, United States
Units Affected: 7668 bottles
Distributed To: Nationwide

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.