Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures
Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The issue is a failure in dissolution specifications, which is a quality control defect rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Forest Pharmaceuticals Inc. is recalling 3,950 packs of Namenda XR (memantine HCl) extended-release capsules. The specific product affected is the 28-capsule, 4-week titration pack containing 7 mg, 14 mg, 21 mg, and 28 mg capsules. The recall involves Lot 1113661 with an expiration date of 01/15.
The recall was initiated because three lots of the product failed stability dissolution testing. This means the capsules may not release the medication as intended. The affected products were distributed nationwide and in Puerto Rico.
Consumers who have this specific lot of Namenda XR should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatment options.
The recalled product
- Product
- 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.
- Manufacturer
- Forest Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,950
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1113661 Exp. 01/15
Distribution
Part of a larger recall action
This product is one of 3 recalled by Forest Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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