Memantine Hydrochloride

Memantine Hydrochloride recalls: 5 FDA reports

Recalls involving Memantine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.

5Reports
0Class I
1Ongoing
2026-04-22Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class III3
Class II2

By year reported

YearReports
20191
20203
20261
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packa

D-0485-2026  ·  Class II  ·  reported 2026-04-22  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications
Product
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Where it went
US Nationwide.
How much
N/A

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufac

D-1262-2020  ·  Class III  ·  reported 2020-05-20  ·  Terminated

Why it was recalled
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Product
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Where it went
AL, FL, IA, NY, OH, TX
How much
678 cartons

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Ma

D-0844-2020  ·  Class III  ·  reported 2020-02-26  ·  Terminated

Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
Where it went
U.S.A. Nationwide
How much
246 Cartons

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin P

D-0855-2020  ·  Class II  ·  reported 2020-02-19  ·  Terminated

Why it was recalled
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Product
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Where it went
Nationwide within the United States.
How much
6,294 bottles

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and

D-0629-2020  ·  Class III  ·  reported 2019-12-25  ·  Terminated

Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Where it went
Nationwide in the USA
How much
3,726 bottles
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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