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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Jubilant Cadista Pharmaceuticals, Inc.: Donepezil HCL Tablets Recalled for Subpotency

Agency Publication Date: August 31, 2021
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Summary

Jubilant Cadista Pharmaceuticals, Inc. has recalled approximately 14,544 bottles of Donepezil HCL (donepezil hydrochloride) tablets, which is a generic medication used to treat dementia and symptoms of Alzheimer's disease. The recall was issued because testing revealed the tablets were subpotent, meaning they may not contain the full required amount of the active ingredient. This recall affects 5 mg strength tablets sold in 90-count bottles that were distributed nationwide. If you have this medication, you should consult with your healthcare provider or pharmacist to ensure your treatment remains effective.

Risk

Subpotent medication contains less of the active ingredient than prescribed, which can lead to a decrease in the medication's effectiveness. For patients with Alzheimer's, this could result in a temporary loss of symptom control or a lack of expected improvement.

What You Should Do

  1. Check your medication bottle to see if it is 'Donepezil HCL Tablets, USP, 5 mg' in a 90-count bottle.
  2. Look for lot number DN120006A with an expiration date of 12/2021 and the National Drug Code (NDC) 59746-329-90 on the label.
  3. Contact your healthcare provider or pharmacist immediately for guidance if your medication matches the affected lot number.
  4. Return any unused tablets from the recalled lot to the pharmacy where they were purchased for a refund.
  5. Contact Jubilant Cadista Pharmaceuticals, Inc. 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
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Donepezil HCL Tablets, USP, 5 mg (90-count bottle)
Model:
NDC 59746-329-90
Lot Numbers:
DN120006A (Exp 12/2021)
Date Ranges: Expiration date 12/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88523
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Manufactured In: India, United States
Units Affected: 14,544 bottles
Distributed To: Nationwide

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.