Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures
Forest Pharmaceuticals is recalling 156 bottles of Namenda XR 7 mg capsules because they failed stability dissolution testing. The affected product was distributed nationwide and in Puerto Rico.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Forest Pharmaceuticals Inc. is recalling 156 bottles of Namenda XR (memantine HCl) 7 mg extended release capsules. The recall involves product with NDC 0456-3407-33, Lot 1111291, and an expiration date of 02/16. The affected product was distributed nationwide and in Puerto Rico.
The recall was initiated because three lots of the product failed stability dissolution testing. Dissolution testing ensures that the medication releases the active ingredient at the correct rate; failing this specification may affect the drug's performance.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Forest Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 156
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 1111291 Exp. 02/16
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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