Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Forest Pharmaceuticals Inc

NDC code

0456-3400-29

Origin

MO, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1064-2014

Other Memantine recalls

See all

Class II · Moderate risk Ongoing Mar 24, 2026

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed…

Reason Failed Dissolution Specifications

The Harvard Drug Group LLC NDC 0904-6734-61 D-0485-2026

Class II · Moderate risk Terminated Mar 15, 2021

Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0456-1214-30 D-0418-2021

Class III · Low risk Terminated Apr 24, 2020

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin…

Reason Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

The Harvard Drug Group D-1262-2020

Class II · Moderate risk Terminated Feb 12, 2020

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

Reason Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-248-06 D-0855-2020

Class III · Low risk Terminated Dec 13, 2019

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

Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.

The Harvard Drug Group NDC 0904-6735-61 D-0844-2020