Class II · Moderate risk
Lurasidone Hydrochloride Tablets 120mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Is Lurasidone recalled?
Not under an active recall.
Lurasidone was recalled 3 times in the past — all now closed. Most recent: Jan 18, 2024.
Most common reason: Microbial contamination (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lurasidone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lurasidone recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone HCL
Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.
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