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Antipsychotics

FDA recalls

17 rows

DateCompany and reasonClass
Aug 26, 2026Macleods Pharmaceuticals Limited
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.		Class III · Ongoing
May 26, 2026Ajanta Pharma USA Inc
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.		Class II · Ongoing
Aug 27, 2025Ascend Laboratories, LLC
Superpotent drug		Class II · Ongoing
Nov 24, 2024Macleods Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications		Class II · Ongoing
Apr 8, 2024Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Cross Contamination with Other Products		Class III · Ongoing
Mar 16, 2023Ascend Laboratories, LLC
Out of specification (OOS) for Spectroscopic Identification test by IR.		Class II · Ongoing
Feb 6, 2023Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.		Class II · Terminated
Feb 15, 2022Macleods Pharma Usa Inc
cGmp Deviations		Class II · Terminated
Jan 25, 2022Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.		Class II · Terminated
Jun 9, 2020Alembic Pharmaceuticals Limited
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.		Class II · Terminated
Nov 13, 2018Ascend Laboratories LLC
Presence of Foreign Substance; metal shard found in tablet		Class II · Terminated
Jan 18, 2018American Health PAckaging
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.		Class II · Terminated
Jan 9, 2018Hetero Labs, Ltd. - Unit III
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.		Class II · Terminated
Oct 12, 2016Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.		Class III · Terminated
Sep 10, 2013Janssen Pharmaceuticals, Inc.
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample		Class II · Terminated
Sep 10, 2013Janssen Pharmaceuticals, Inc.
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample		Class II · Terminated
Nov 1, 2012Bristol Myers Squibb Manufacturing Company
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).