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Unrated Drug recall · FDA · Published December 2, 2019

Jubilant Cadista Amantadine Tablets Recall: Foreign Object in Single Tablet

Jubilant Cadista recalls 100mg Amantadine Hydrochloride tablets due to foreign substance in some tablets. This is a prescription-only product with potential safety concerns.

🇺🇸 FDA recall #D-0576-2020DrugJubilant Cadista ›
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Recalling firmJubilant Cadista Pharmaceuticals, Inc.207 Kiley Dr · Salisbury, MD 21801-2249
✎ GovInfoNow plain-language explainer

What happened, in plain English

Jubilant Cadista is recalling 100mg Amantadine Hydrochloride tablets that may contain a foreign object. This could pose a safety risk if the foreign object is ingested. The product is prescription-only and sold in 100-count bottles. Read more at govinfonow.com/recall/37667-jubilant-cadista-amantadine-tablets-recall-foreign-object-in-single-tablet.

Source Summary by GovInfoNow · govinfonow.com/recall/37667-jubilant-cadista-amantadine-tablets-recall-foreign-object-in-single-tablet · Updated October 5, 2026 · FDA enforcement record: FDA #D-0576-2020

Cite this page

“Jubilant Cadista Amantadine Tablets Recall: Foreign Object in Single Tablet.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37667-jubilant-cadista-amantadine-tablets-recall-foreign-object-in-single-tablet. Based on FDA recall #D-0576-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0576-2020%22&limit=1).

Why it’s dangerous

The recall is for tablets that may contain a foreign object. If ingested, this could cause injury or health issues. The product is prescription-only and requires medical supervision.

Who’s affected

Prescription patients who have purchased the recalled Amantadine Hydrochloride tablets from the manufacturer. Those with specific medical conditions requiring this medication are at higher risk.

How to tell if you have this one

Check for the product name 'Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle' with NDC 59746-699-01. The product was manufactured by Jubilant Generics Ltd. in India and marketed by Jubilant Cadista Pharmaceuticals Inc. in the US.

  • Brand
    Jubilant Cadista
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 59746-699-01 on the product label to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Dec 2, 201912. FDA classified it Class II: Dec 6, 201923. Published in FDA’s Enforcement Report: Dec 18, 201934. FDA terminated the recall: Oct 14, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a potential foreign object in some tablets, so it's not safe to use without checking the recall status.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0576-2020 (December 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0576-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA