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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Pharmaceuticals USA Inc: Acyclovir and Carvedilol Tablets Recalled Due to Label Mix-Up

Agency Publication Date: May 8, 2019
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Summary

Zydus Pharmaceuticals USA Inc. has recalled approximately 3,900 units of Acyclovir Tablets (400 mg) and Carvedilol Tablets (6.25 mg) because of a label mix-up. A report was received stating that a bottle labeled as Acyclovir actually contained Carvedilol, a medication used for different medical purposes. These prescription medications were manufactured by Cadila Healthcare Ltd. in India and distributed nationwide across the United States.

Risk

Taking the wrong medication due to a labeling error can result in serious health consequences, such as receiving a blood pressure medication (Carvedilol) instead of an antiviral (Acyclovir), which may cause unintended low blood pressure or failure to treat the primary infection.

What You Should Do

  1. Immediately check your prescription bottles for Acyclovir Tablets (400 mg) in 100-count bottles (NDC 68382-791-01) or Carvedilol Tablets (6.25 mg) in 500-count bottles (NDC 68382-093-05).
  2. Look for lot number Z804517 with an expiration date of Nov 30, 2020, on the product packaging.
  3. If you have a bottle from this lot, contact your healthcare provider or pharmacist immediately to ensure you are taking the correct medication and to discuss any health concerns.
  4. Return any unused or mislabeled product to the pharmacy where it was purchased for a refund.
  5. Contact Zydus Pharmaceuticals USA Inc. at their Pennington, NJ office or through their official website for further instructions regarding this recall.
  6. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to pharmacy for refund

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

Affected Products

Product: Acyclovir Tablets, USP, 400 mg (100-count bottle)
Model:
NDC 68382-791-01
Recall #: D-1272-2019
Lot Numbers:
Z804517 (Nov 30, 2020)
Date Ranges: exp Nov 30, 2020
Product: Carvedilol Tablets, USP, 6.25 mg (500-count bottle)
Model:
NDC 68382-093-05
Recall #: D-1273-2019
Lot Numbers:
Z804517 (exp Nov 30, 2020)
Date Ranges: exp Nov 30, 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82714
Status: Resolved
Manufacturer: Zydus Pharmaceuticals USA Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 3900
Distributed To: Nationwide
Agency Last Updated: May 21, 2019

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.