Memantine Hydrochloride Capsule, Extended Release
FDA Recall NDC 0904-6735
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Memantine Hydrochloride (NDC 0904-6735). A significant event, classified as Class II, was initiated on Mar 24, 2026 by Major Pharmaceuticals. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Mar 24, 2026
Apr 22, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98672
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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
Batch or Lot Expiration Information
Lot# N02425, Exp Date: 05/31/2027.
Affected Packages Involved in this Recall
0904-6734-61Product
0904-6736-61Product
0904-6737-61Product
0904-6735-61Product
Class III Terminated
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Apr 24, 2020
May 20, 2020
678 cartons
Recall Profile & Regulatory Data
Event ID
85566
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AL, FL, IA, NY, OH, TX
Termination Date
Aug 19, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# : M02199D, M02246D, Exp 5/2020
Affected Packages Involved in this Recall
0904-6734-61Product
0904-6736-61Product
0904-6737-61Product
0904-6735-61Product
Class III Terminated
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Dec 13, 2019
Feb 26, 2020
246 Cartons
Recall Profile & Regulatory Data
Event ID
84955
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Nov 04, 2020
Product Description
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
Batch or Lot Expiration Information
Lot# M02465D
Affected Packages Involved in this Recall
0904-6734-61Product
0904-6736-61Product
0904-6737-61Product
0904-6735-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
