Class II · Moderate risk
Lacosamide Tablets
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Is Lacosamide recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Lacosamide (9 total). Check the affected lots below.
Most common reason: cGMP deviation (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lacosamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lacosamide recalls in 2026
1 initiated in 2026, 9 in total — newest first
Class II · Moderate risk
Lacosamide Oral Solution
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II · Moderate risk
Lacosamide Tablets 150mg
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets 200mg
CGMP Deviations
Class III · Low risk
Lacosamide Oral Solution
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class II · Moderate risk
VIMPAT (lacosamide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
VIMPAT (lacosamide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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