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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

Zydus Pharmaceuticals USA Inc: Paroxetine Tablets Recalled Due to Presence of Risperidone Tablets

Agency Publication Date: September 11, 2017
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Summary

Zydus Pharmaceuticals USA Inc is recalling approximately 44,800 bottles of Paroxetine (paroxetine tablets USP), 30mg, because bottles were found to contain a different medication, Risperidone (risperidone tablets). This recall involves 30-count bottles of the prescription antidepressant. Taking the wrong medication can lead to serious adverse health effects or the failure to treat the condition for which the Paroxetine was originally prescribed. Consumers should immediately verify their medication and contact their healthcare provider if they suspect they have received the incorrect tablets.

Risk

The presence of a foreign medication (Risperidone) in a bottle labeled as Paroxetine poses a significant risk of accidental ingestion of the wrong drug, which can lead to unexpected side effects, drug interactions, or a lack of treatment for the patient's actual condition.

What You Should Do

  1. Check your prescription bottle for Paroxetine tablets USP, 30mg, in 30-count bottles with NDC 68382-099-06 and UPC 3 6838209906 8.
  2. Verify if your bottle belongs to Lot Z701133 with an expiration date of 03/19.
  3. If you identify the affected lot, compare the tablets inside the bottle to your previous prescriptions; if any tablets look different or if you are unsure, do not consume them.
  4. Contact your healthcare provider or pharmacist immediately for guidance on how to identify the correct medication and to obtain a safe replacement.
  5. Return any unused product from the affected lot to your pharmacy for a refund and contact Zydus Pharmaceuticals USA Inc at their Pennington, NJ location for further instructions.
  6. For additional questions, 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

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Paroxetine tablets USP, 30mg (30-count bottle)
Model:
NDC 68382-099-06
UPC Codes:
368382099068
Lot Numbers:
Z701133 (Exp 03/19)
Date Ranges: Expiration 03/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77963
Status: Resolved
Manufacturer: Zydus Pharmaceuticals USA Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 44800 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.