Class II · Moderate risk
Loxapine Capsules
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Is Loxapine recalled?
Not under an active recall.
Loxapine was recalled 10 times in the past — all now closed. Most recent: May 1, 2018.
Most common reason: Labeling / mix-up (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Loxapine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Loxapine recalls on record
none so far in 2026; 10 on record, newest first
Class II · Moderate risk
Loxapine Capsules
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Loxapine
Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD46426_1, EXP: 5/15/2014.
Class III · Low risk
Loxitane Capsules
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
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