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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66838

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 13, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Forest Pharmaceuticals Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33

D-1063-2014
Recall number
D-1063-2014
Initiated
November 13, 2013
Classification
Class III
Status
Terminated
Quantity
156 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot 1111291 Exp. 02/16

Distribution pattern

Nationwide and Puerto Rico.

drug · product 2 of 3

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.

D-1064-2014
Recall number
D-1064-2014
Initiated
November 13, 2013
Classification
Class III
Status
Terminated
Quantity
3,950 packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot 1113661 Exp. 01/15

Distribution pattern

Nationwide and Puerto Rico.

drug · product 3 of 3

Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.

D-1065-2014
Recall number
D-1065-2014
Initiated
November 13, 2013
Classification
Class III
Status
Terminated
Quantity
111,384 sample packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot 1112467 Exp. 02/15

Distribution pattern

Nationwide and Puerto Rico.