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.

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

Recall #: D-1064-2014
Affected scope: 3,950 packs
Initiated: November 13, 2013

Compiled from official public sources by the publisher. · Updated September 2026

Forest Pharmaceuticals Inc recalled Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended releas… - a low-severity action.

Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended releas… was recalled by Forest Pharmaceuticals Inc in February 12, 2014. Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution t…. Check the official notice for the remedy. Verify recall #D-1064-2014 with the FDA Drug before acting.

The recall

Forest Pharmaceuticals Inc issued this low-severity FDA Drug recall-Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution t….

Low
severity level: Class III
classification: February 12, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1064-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Reason for recall

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-1064-2014
Date reported	February 12, 2014
Date initiated	November 13, 2013
Recalling firm	Forest Pharmaceuticals Inc
Firm location	Earth City, MO
Affected scope	3,950 packs
Distribution	Nationwide and Puerto Rico.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-1064-2014) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 12, 2014. Severity: Low. Recall number: D-1064-2014.

Where was the recalled product distributed? ▼

Distribution: Nationwide and Puerto Rico..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

Glucotrol XL (glipizide) extended release… 2014-02-12 Glipizide XL (glipizide) extended release… 2014-02-12 Ofloxacin Ophthalmic Solution, USP 0.3%, … 2014-02-12 Ofloxacin Ophthalmic Solution, USP 0.3%, … 2014-02-12

Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Cefepime for Injection USP and Dextrose I… 2014-02-12 Dicopanol FusePaq Kit for Oral Suspension… 2014-02-12 50 mg Nitroglycerin in 5% Dextrose Inject… 2014-02-12 Diclofenac Sodium and Misoprostol Delayed… 2014-02-12

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported February 12, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026