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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

Jubilant Cadista Pharmaceuticals, Inc.: Amantadine Hydrochloride Tablets Recalled for Presence of Foreign Object

Agency Publication Date: December 6, 2019
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Summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 1,824 bottles of Amantadine Hydrochloride (100 mg) tablets because a foreign object was discovered inside a single tablet. Amantadine Hydrochloride is a prescription medication used to treat Parkinson's disease and certain viral infections. This nationwide recall affects 100-count bottles from a specific lot manufactured in India and distributed across the United States. You should contact your healthcare provider or pharmacist immediately to discuss your treatment if you have this medication.

Risk

The presence of a foreign substance or object within a tablet poses a choking hazard or potential internal injury if ingested. While only a single tablet was reported to contain a foreign object, the entire lot is being recalled to ensure patient safety.

What You Should Do

  1. Check your prescription bottle label for Amantadine Hydrochloride Tablets, 100 mg, in 100-count bottles with NDC 59746-699-01.
  2. Verify if your bottle belongs to Lot NT119005A with an expiration date of 07/2021.
  3. If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication.
  4. Return any unused product from the affected lot to your pharmacy to receive a refund.
  5. Contact Jubilant Cadista Pharmaceuticals, Inc. at their Salisbury, Maryland location or through your pharmacist for further instructions regarding the return process.
  6. For additional questions or to report a problem, 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 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: Amantadine Hydrochloride Tablets, 100 mg (100-count bottle)
Model:
NDC 59746-699-01
Recall #: D-0576-2020
Lot Numbers:
NT119005A (Exp 07/2021)
Date Ranges: Exp 07/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84396
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 1,824 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.