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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

Memantine Hydrochloride Extended-Release Recalled for Dissolution Failure

Agency Publication Date: April 10, 2026
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Summary

The Harvard Drug Group LLC is recalling one lot of Memantine Hydrochloride Extended-Release (7 mg capsules) because the medication failed to meet dissolution specifications during testing. This prescription medication, used to treat symptoms of Alzheimer's disease, was packaged under the Major Pharmaceuticals brand in 100-count blister packs. No injuries or adverse incidents have been reported to date regarding this specific lot.

Risk

A dissolution failure means the medication may not release into the body at the correct rate, which could potentially reduce the drug's effectiveness in managing symptoms or lead to unexpected blood levels of the medication.

What You Should Do

  1. Check your medication packaging for Memantine Hydrochloride Extended-Release, 7 mg capsules with NDC 0904-6734-61 and Lot # N02425 with an Expiration Date of 05/31/2027.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Memantine Hydrochloride Extended-Release (100 Capsules)by Major Pharmaceuticals
Variants: 7 mg, Capsules
Lot Numbers:
N02425 (Exp Date: 05/31/2027)
NDC:
0904-6734-61

Packaged and Distributed by: Major Pharmaceuticals; 10 x 10 blister packs; Rx only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98672
Status: Active
Manufacturer: The Harvard Drug Group LLC
Sold By: Major Pharmaceuticals
Manufactured In: United States
Distributed To: Nationwide
Agency Last Updated: April 17, 2026

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.