Class II · Moderate risk
Aripiprazole Tablets USP
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Is Aripiprazole recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Aripiprazole (29 total). Check the affected lots below.
Most common reason: cGMP deviation (10 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Aripiprazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Aripiprazole recalls in 2026
1 initiated in 2026, 29 in total — newest first
Class II · Moderate risk
Aripiprazole Tablets
Superpotent drug
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class II · Moderate risk
Aripiprazole 5mg tablets
cGMP Deviations
Class II · Moderate risk
Aripiprazole Tablets
Out of specification (OOS) for Spectroscopic Identification test by IR.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Aripiprazole Tablets
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Aripiprazole Tablets
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Class III · Low risk
treatNOW ABILIFY
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class III · Low risk
treatNOW ABILIFY
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
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