The Harvard Drug Group recalls Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:
Harvard Drug Group recalls 28mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution testing in stability checks. This affects Rx-only products with specific NDC and lot numbers.
Lower-risk recall
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Contact the company & request your remedy
What happened, in plain English
The Harvard Drug Group is recalling 28 mg Memantine Hydrochloride Extended-Release Capsules because they failed dissolution testing during stability checks. This means the medication may not release properly in the body, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/37132-harvard-drug-group-memantine-capsules-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/37132-harvard-drug-group-memantine-capsules-recall-failed-dissolution-testing · Updated October 5, 2026 · FDA enforcement record: FDA #D-1262-2020
Cite this page
“Harvard Drug Group Memantine Capsules Recall: Failed Dissolution Testing.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37132-harvard-drug-group-memantine-capsules-recall-failed-dissolution-testing. Based on FDA recall #D-1262-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1262-2020%22&limit=1).
Why it’s dangerous
The capsules failed dissolution testing during routine stability checks. This means the medication might not release properly in the body, which could affect treatment effectiveness. However, the recall does not indicate a risk of serious injury or death.
Who’s affected
Prescription patients using the recalled Memantine Hydrochloride Extended-Release Capsules. Patients with specific NDC numbers and lot dates are most at risk.
How to tell if you have this one
Check for NDC number 0904-6735-61 and lot numbers M02199D or M02246D with expiration date 5/2020. The product is prescription-only and sold in 100-capsule cartons.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Verify the NDC number 0904-6735-61 and lot numbers M02199D or M02246D with expiration date 5/2020.
Questions people ask
Is this product safe to use?
The recall indicates failed dissolution testing, but the product is not stated to be unsafe for use. Patients should check if they have the specific NDC and lot numbers listed.
What should I do if I have this product?
The recall does not specify a remedy, so check the product details to see if it matches the NDC and lot numbers listed. If it does, contact the manufacturer for further instructions.
How can I confirm if I have the recalled product?
Look for NDC number 0904-6735-61 and lot numbers M02199D or M02246D with expiration date 5/2020 on the product packaging.
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-1262-2020 — The Harvard Drug Group The Harvard Drug Group Hello, I own a The Harvard Drug Group that is covered by recall D-1262-2020 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-1262-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1262-2020 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.