Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is ARIPIPRAZOLE recalled?

The FDA has recorded 12 recalls of ARIPIPRAZOLE (2023–2025) , recalled under brands like ABILIFY, ARIPIPRAZOLE. 6 still ongoing.

0
Class I (most serious)
8
Class II
4
Class III
6
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of ARIPIPRAZOLE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection. 6
Cross Contamination with Other Products 4
Superpotent drug 1
Out of specification (OOS) for Spectroscopic Identification test by IR. 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distribute Class II ongoing
Ascend Laboratories, LLC 2025-08-28 lots: Lot #: 24144162, Exp. Date 09/2027
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-c Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025;
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-c Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100- Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2005474, Exp 9/30/2023; P2100001, Exp 12/31/2023; P2100789, P2100790, Exp 1/31/2024; P2101319, Exp 2/28/2024; P2102147, P2102148, Exp 3/31/2024; P2104084, Exp 6/30/2024; P2105410, P2107233, P2105411, Exp 7/31/2024; P2106671, P2106673, P2106675, Exp 9/30/2024; P2200428, P2200429, P2200430, Exp 12/31/2024; P2203333, P2203334, Exp 5/31/2025; b) P2102940 Exp. 3/31/2023, P2105793, Exp. 7/31/2024;
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100 Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025;
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Class II ongoing
Ascend Laboratories, LLC 2023-03-17 lots: Lot #22143120, Exp. Date: June 2024
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025; b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P2206130, Exp. Date 8/31/2024;
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-co Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024; P2107404, P2107029, Exp. Date 10/31/2024; P2200260, P2200265, Exp. Date 12/31/2024; P2202067, P2202068, Exp. Date 3/31/2025; P2204239, Exp. Date 7/31/2025; b) P2006800 Exp. Date 11/30/2023; P2102141, Exp. Date 3/31/2024; P2104085, Exp. Date 6/30/2024; P2107031, P2107466, Exp. Date 10/31/2024;
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5 Class III ongoing
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 2024-04-09 lots: Lot # AMS00223A, Exp 07/31/2025
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59 Class III ongoing
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 2024-04-09 lots: Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs ( Class III ongoing
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 2024-04-09 lots: Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5 Class III ongoing
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 2024-04-09 lots: Lot # APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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