FDA Drug Recalls

Recalls / Active ingredient / Aripiprazole

Aripiprazole

17 FDA drug recalls involving the active ingredient “Aripiprazole.

DateClassProductFirm
2025-08-28Class IIAripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Ascend Laboratories, LLC
2024-04-09Class IIIAbilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, ISecond Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
2024-04-09Class IIIAbilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, InSecond Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
2024-04-09Class IIIAbilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, ISecond Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
2024-04-09Class IIIAbilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blistSecond Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
2023-03-17Class IIAripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories LAscend Laboratories, LLC
2023-02-07Class IIAripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210Accord Healthcare, Inc.
2023-02-07Class IIAripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-coAccord Healthcare, Inc.
2023-02-07Class IIAripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 Accord Healthcare, Inc.
2023-02-07Class IIAripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5Accord Healthcare, Inc.
2023-02-07Class IIAripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9;Accord Healthcare, Inc.
2023-02-07Class IIAripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2Accord Healthcare, Inc.
2022-01-26Class IIAripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, BridgewateCARDINAL HEALTHCARE
2020-06-10Class IIAripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals LimiAlembic Pharmaceuticals Limited
2018-01-19Class IIAripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 6068AMERICAN HEALTH PACKAGING
2018-01-10Class IIAripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. PiHetero Labs, Ltd. - Unit III
2012-11-02Class IIABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical IncBristol Myers Squibb Manufacturing Company