Class II · Moderate risk
Rufinamide Tablets 200mg
CGMP Deviations
Is Rufinamide recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Rufinamide (4 total). Check the affected lots below.
Most common reason: cGMP deviation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Rufinamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Rufinamide recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Banzel (rufinamide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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