Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Is Memantine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Memantine (12 total). Check the affected lots below.
Most common reason: Dissolution failure (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Memantine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Memantine recalls in 2026
1 initiated in 2026, 12 in total — newest first
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Memantine Hydrochloride Extended-Release Capsules
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class II · Moderate risk
Memantine Hydrochloride Extended Release Capsules
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class II · Moderate risk
Memantine Hydrochloride Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Memantine Hydrochloride Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Memantine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
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