CLASS III Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Namenda XR (memantine HCl), sample pack, 28 mg recalled
Forest Pharmaceuticals is recalling Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, 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
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-1065-2014
- 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), 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.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Is Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules recalled?
Yes. Forest Pharmaceuticals recalled Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules on 13 Nov 2013. The recall is Class III and its status is Terminated. Recall number D-1065-2014.
Why was it recalled?
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Which lots are affected?
Lot 1112467 Exp. 02/15
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Forest Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bystolic (nebivolol) tablets, 20 mg/tablet recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Bystolic (nebivolol) tablets, 20 mg/tablet recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Bystolic (nebivolol), 20 mg/tablet recalled by Forest PharmaceuticalsBystolic | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Namenda XR (memantine HCl) recalled by Forest Pharmaceuticals | Forest Pharmaceuticals | Potency & Assay | Nationwide |