The Harvard Drug Group recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only,
The Harvard Drug Group recalls 28mg Memantine Hydrochloride Extended-release Capsules due to failed dissolution specifications observed in stability studies. This may affect medication effectiveness.
Lower-risk recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Contact the company & request your remedy
What happened, in plain English
The Harvard Drug Group is recalling 28mg Memantine Hydrochloride Extended-release Caps: the product failed dissolution tests during stability studies, which could mean it doesn't work as intended. This is a medication recall for people prescribed this drug. Read more at govinfonow.com/recall/37656-memantine-capsules-recall-failed-dissolution-specifications-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37656-memantine-capsules-recall-failed-dissolution-specifications-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0844-2020
Cite this page
“Memantine Capsules Recall: Failed Dissolution Specifications Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37656-memantine-capsules-recall-failed-dissolution-specifications-risk. Based on FDA recall #D-0844-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0844-2020%22&limit=1).
Why it’s dangerous
The product failed dissolution specifications during stability testing. This means the medication might not release properly in the body, potentially reducing its effectiveness. However, the recall does not indicate a risk of serious injury or death.
Who’s affected
People prescribed Memantine Hydrochloride Extended-release Capsules 28mg by a doctor. Those who have the product are most at risk.
How to tell if you have this one
Check for Memantine Hydrochloride Extended-release Capsules 28mg in 100-count Unit Dose Cartons. The product was manufactured by Lupin Pharmaceuticals and distributed by Major Pharmaceuticals. Lot number M02465D is associated with this recall.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, strength (28mg), and packaging (100-count Unit Dose Cartons) to confirm if it matches the recalled item.
Questions people ask
Is this product safe to use?
The recall states the product failed dissolution specifications during stability testing, which could mean it doesn't work as intended. However, the recall does not indicate a risk of serious injury or death.
What should I do if I have this product?
The recall does not specify a remedy, so you should check with your doctor or pharmacist about whether to continue using the product.
How can I tell if I have the recalled product?
Check for Memantine Hydrochloride Extended-release Capsules 28mg in 100-count Unit Dose Cartons. The product was manufactured by Lupin Pharmaceuticals and distributed by Major Pharmaceuticals with Lot number M02465D.
Contact The Harvard Drug Group
We’ve drafted a message you can send The Harvard Drug Group to request your refund or repair — edit it as you like.
Subject: Recall D-0844-2020 — The Harvard Drug Group The Harvard Drug Group Hello, I own a The Harvard Drug Group that is covered by recall D-0844-2020 from The Harvard Drug Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0844-2020 (December 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0844-2020 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.