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Lower risk Drug recall · FDA · Published March 24, 2026

Harvard Drug Group Memantine Capsules Recall: Failed Dissolution Specifications

Harvard Drug Group recalls 7mg Memantine Hydrochloride Extended-Release capsules due to failed dissolution specifications. This may affect medication effectiveness. Contact for return instructions.

🇺🇸 FDA recall #D-0485-2026DrugHarvard Drug Group ›
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Recalling firmThe Harvard Drug Group LLC7000 Cardinal Pl · Dublin, OH 43017-1091
✎ GovInfoNow plain-language explainer

What happened, in plain English

Harvard Drug Group is recalling 7mg Memantine Hydrochloride Extended-Release capsules because they failed dissolution specifications. This could mean the medication doesn't work as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/31392-harvard-drug-group-memantine-capsules-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/31392-harvard-drug-group-memantine-capsules-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0485-2026

Cite this page

“Harvard Drug Group Memantine Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31392-harvard-drug-group-memantine-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0485-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2026%22&limit=1).

Why it’s dangerous

The capsules failed to dissolve properly as intended, which could lead to inconsistent medication levels in the body. This might reduce the effectiveness of the treatment for conditions like Alzheimer's disease.

Who’s affected

People prescribed this medication for conditions like Alzheimer's disease who have the specific lot number N02425. Those using the medication as directed are most at risk.

How to tell if you have this one

Check for the product name 'Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs)' with lot number N02425 and expiration date 05/31/2027.

  • Brand
    Harvard Drug Group
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the lot number and expiration date on the packaging to confirm if the product is affected.

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

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Mar 24, 202612. FDA classified it Class II: Apr 17, 202623. Published in FDA’s Enforcement Report: Apr 22, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-0485-2026 (March 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0485-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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