CLASS III Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report

Namenda XR (memantine HCl), titration pack (7 mg, 14 mg recalled

Forest Pharmaceuticals is recalling Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended, distributed nationwide in the US. The recall was initiated on 13 Nov 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 1113661 Exp. 01/15

Quantity recalled3,950 packs

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1064-2014
FDA event ID: 66838
Recalling firm: Forest Pharmaceuticals, Earth City, MO
Classification: Class III
Status: Terminated
Recall initiated: 13 Nov 2013
FDA classified: 4 Feb 2014
Reported: 12 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

13 Nov 2013	Recall initiated by company
4 Feb 2014	Classified by FDA	+83 days
12 Feb 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.

Where it was distributed

Nationwide and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Which lots are affected?

Lot 1113661 Exp. 01/15

Where was it sold?

Nationwide and Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 66838

This product is part of a recall event; the main page for the event is Namenda XR (memantine HCl) recalled by Forest Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2014	CLASS III	Namenda XR (memantine HCl) recalled by Forest Pharmaceuticals	Forest Pharmaceuticals	Potency & Assay	Nationwide
12 Feb 2014	CLASS III	Namenda XR (memantine HCl), sample pack, 28 mg recalled	Forest Pharmaceuticals	Potency & Assay	Nationwide

More recalls from Forest Pharmaceuticals

All 6

Reported	Class	Recall	Company	Reason	Where
29 Oct 2014Drug	CLASS II	Bystolic (nebivolol) tablets, 20 mg/tablet recalled	Forest Pharmaceuticals	Potency & Assay	Nationwide
9 Jul 2014Drug	CLASS II	Bystolic (nebivolol) tablets, 20 mg/tablet recalled	Forest Pharmaceuticals	Potency & Assay	Nationwide
28 May 2014Drug	CLASS II	Bystolic (nebivolol), 20 mg/tablet recalled by Forest PharmaceuticalsBystolic	Forest Pharmaceuticals	Potency & Assay	Nationwide
12 Feb 2014Drug	CLASS III	Namenda XR (memantine HCl), sample pack, 28 mg recalled	Forest Pharmaceuticals	Potency & Assay	Nationwide
12 Feb 2014Drug	CLASS III	Namenda XR (memantine HCl) recalled by Forest Pharmaceuticals	Forest Pharmaceuticals	Potency & Assay	Nationwide

Other Namenda (memantine recalls

All 3

Reported	Class	Recall	Company	Reason	Where
12 Feb 2014Drug	CLASS III	Namenda XR (memantine HCl), sample pack, 28 mg recalled	Forest Pharmaceuticals	Potency & Assay	Nationwide
12 Feb 2014Drug	CLASS III	Namenda XR (memantine HCl) recalled by Forest Pharmaceuticals	Forest Pharmaceuticals	Potency & Assay	Nationwide