Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Riluzole recalled?

Not under an active recall. Riluzole was recalled 3 times in the past — all now closed. Most recent: Oct 20, 2023.

Most common reason: Labeling / mix-up (2 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Riluzole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Riluzole recalls on record

none so far in 2026; 3 on record, newest first
Class II · Moderate risk

Tiglutik (riluzole)

Failed Viscosity Specifications: Out-of-specification test results for viscosity

Terminated Failed specification Itf Pharma INC D-0115-2024
Class II · Moderate risk

Riluzole

Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-813-2014
Class II · Moderate risk

RILUZOLE Tablet

Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-705-2014