US Drug Recall Register
Class III · Low risk Terminated Initiated Nov 13, 2013 (13 years ago)

Namenda XR

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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.

Recalling firm
Forest Pharmaceuticals Inc
NDC code
0456-3428-05
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1065-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Memantine recalls

See all
Class II · Moderate risk Terminated

Namzaric

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0456-1214-30 D-0418-2021
Class III · Low risk Terminated

Memantine Hydrochloride Extended-Release Capsules

Reason Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

The Harvard Drug Group D-1262-2020
Class II · Moderate risk Terminated

Memantine Hydrochloride Extended Release Capsules

Reason Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-248-06 D-0855-2020
Class III · Low risk Terminated

Memantine Hydrochloride Extended-release Capsules

Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.

The Harvard Drug Group NDC 0904-6735-61 D-0844-2020