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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

Lupin Pharmaceuticals Inc.: Memantine Hydrochloride Extended-release Capsules Recalled for Dissolution Failure

Agency Publication Date: December 19, 2019
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Summary

Lupin Pharmaceuticals Inc. is voluntarily recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules (28mg), a medication used to treat symptoms of Alzheimer's disease. The recall was initiated because stability testing showed the drug was not dissolving at the correct rate, which can affect how the medication is released into the body. This recall includes 90-count and 500-count bottles that were distributed nationwide in the United States.

Risk

If a medication does not dissolve according to specifications, it may release the active ingredient too slowly or too quickly, potentially reducing the effectiveness of the treatment or causing unexpected side effects.

What You Should Do

  1. Check your prescription bottles for Memantine Hydrochloride Extended-release Capsules (28mg) in 90-count (NDC 68180-249-09) or 500-count (NDC 68180-249-02) sizes.
  2. Verify if your bottle matches lot numbers H901787 or H901788 with an expiration date of March 2021.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are taking this medication.
  4. Return any unused product from the affected lots to the pharmacy where you purchased it for a refund.
  5. Contact Lupin Pharmaceuticals Inc. for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint line 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: Memantine Hydrochloride Extended-release Capsules, 28mg (90-count bottle)
Model:
NDC 68180-249-09
Lot Numbers:
H901787 (Exp March 2021)
H901788 (Exp March 2021)
Date Ranges: Expiration March 2021
Product: Memantine Hydrochloride Extended-release Capsules, 28mg (500-count bottle)
Model:
NDC 68180-249-02
Lot Numbers:
H901787 (Exp March 2021)
H901788 (Exp March 2021)
Date Ranges: Expiration March 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84463
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States, India
Units Affected: 3,726 bottles
Distributed To: Nationwide
Agency Last Updated: December 23, 2019

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.