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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: Paroxetine Tablets Recalled Due to Presence of Risperidone Tablets

Agency Publication Date: November 30, 2017
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Summary

Zydus Pharmaceuticals USA Inc. has recalled 19,812 bottles of Paroxetine (paroxetine hydrochloride), a prescription medication used to treat depression and anxiety. The recall was initiated because foreign tablets of Risperidone, a medication used for mood disorders, were found inside bottles labeled as Paroxetine. This medication error affects 30 mg strength tablets in 30-count, 500-count, and 1,000-count bottles that were distributed nationwide.

Risk

Taking the incorrect medication can lead to serious health complications, as consumers may unintentionally ingest Risperidone instead of their prescribed Paroxetine. This could result in side effects associated with Risperidone or the failure to treat the condition for which Paroxetine was originally prescribed.

What You Should Do

  1. Immediately check your medication bottle for Paroxetine Tablets USP, 30 mg, with lot numbers Z701308, Z701309, or Z701310 and an expiration date of April 2019.
  2. Compare the tablets inside the bottle; if any tablets appear different in size, shape, or color from the others, do not consume them.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you suspect you have received the incorrect medication or have already taken it.
  4. Return any unused product from the affected lots to your pharmacy for a refund and to ensure you receive the correct prescription.
  5. Contact Zydus Pharmaceuticals USA Inc. at their Pennington, NJ location for further instructions regarding this recall.
  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

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: Paroxetine Tablets USP (30 mg, 30 count bottle)
Model:
NDC 68382-099-06
Recall #: D-0101-2018
Lot Numbers:
Z701308 (exp April 2019)
Date Ranges: April 2019
Product: Paroxetine Tablets USP (30 mg, 500 count bottle)
Model:
NDC 68382-099-05
Recall #: D-0101-2018
Lot Numbers:
Z701309 (exp April 2019)
Date Ranges: April 2019
Product: Paroxetine Tablets USP (30 mg, 1000 count bottle)
Model:
NDC 68382-099-10
Recall #: D-0101-2018
Lot Numbers:
Z701310 (exp April 2019)
Date Ranges: April 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78612
Status: Resolved
Manufacturer: Zydus Pharmaceuticals USA Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 19812 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.