Aripiprazole recalls

The FDA has published 27 recalls involving Aripiprazole since 2013. The latest was reported on 24 Jun 2026. Most were for manufacturing (cgmp) deviations. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls27since 2013

Last 12 months1reported

Class I00% of total

Ongoing7latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 1 0 0Nov 0 0 0Feb 0 0 0May 1 0 0Aug 0 0

Severity split

Class I 0 0%Class II 21 78%Class III 6 22%

Why aripiprazole is recalled

Companies

Accord Healthcare622%
Second Tokushima Factory Otsuka Pharmaceutical415%
Apotex311%
Ascend Laboratories27%
The Harvard Drug Group27%
Aidapak Services27%
Ajanta Pharma USA14%
Cardinal Healthcare14%

Brands

Aripiprazole1348%
Abilify519%

By year

202614%
202514%
2024519%
2023830%
202214%
2020415%
201827%
201727%
201427%
201314%

Ongoing aripiprazole recalls

7 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole	Ajanta Pharma USA	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	Aripiprazole Tablets, USP, 10 mg recalled by Ascend LaboratoriesAripiprazole	Ascend Laboratories	Potency & Assay	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide

All aripiprazole recalls, newest first

27 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole	Ajanta Pharma USA	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	Aripiprazole Tablets, USP, 10 mg recalled by Ascend LaboratoriesAripiprazole	Ascend Laboratories	Potency & Assay	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
1 May 2024Drug	CLASS III	Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify	Second Tokushima Factory Otsuka Pharmaceutical	Packaging Defects	Nationwide
3 Jan 2024Drug	CLASS II	Aripiprazole Tablets, USP, 5 mg recalled by Cardinal HealthcareAripiprazole	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
26 Apr 2023Drug	CLASS II	Aripiprazole Tablets, USP, 20 mg recalled by Ascend LaboratoriesAripiprazole	Ascend Laboratories	Potency & Assay	Nationwide
12 Apr 2023Drug	CLASS II	Aripiprazole 5mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Aripiprazole Tablets, USP 5 mg recalled by Accord HealthcareAripiprazole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Aripiprazole Tablets, USP 30 mg recalled by Accord HealthcareAripiprazole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Aripiprazole Tablets, USP 20 mg recalled by Accord HealthcareAripiprazole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Aripiprazole Tablets, USP 2 mg recalled by Accord HealthcareAripiprazole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Aripiprazole Tablets, USP 15 mg recalled by Accord HealthcareAripiprazole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Aripiprazole Tablets, USP 10 mg recalled by Accord HealthcareAripiprazole	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
27 Jul 2022Drug	CLASS II	Aripiprazole Tablets, USP 20 mg recalled by Apotex	Apotex	Potency & Assay	Nationwide
9 Dec 2020Drug	CLASS II	Aripiprazole Tablets, USP, 15 mg per unit dose recalled	The Harvard Drug Group	Potency & Assay	Nationwide
9 Dec 2020Drug	CLASS II	Aripiprazole Tablets, 15 mg recalled by Golden State Medical Supply	Golden State Medical Supply	Potency & Assay	Nationwide
25 Nov 2020Drug	CLASS II	Aripiprazole Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
1 Jul 2020Drug	CLASS II	Aripiprazole Tablets, USP, 2 mg recalled by Alembic PharmaceuticalsAripiprazole	Alembic Pharmaceuticals	Other	Nationwide
21 Feb 2018Drug	CLASS II	Aripiprazole Tablets, USP, 10 mg dose blisters [NDC60687 recalledAripiprazole	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
14 Feb 2018Drug	CLASS II	Aripiprazole Tablets, USP, 10 mg recalledAripiprazole	Hetero Labs Ltd. - Unit III	Manufacturing (CGMP) Deviations	NJ
10 May 2017Drug	CLASS III	Aripiprazole Tablets, 2 mg unit dose recalled by The Harvard Drug Group	The Harvard Drug Group	Potency & Assay	Nationwide
15 Feb 2017Drug	CLASS III	Aripiprazole Tablets, 2 mg recalled by Apotex	Apotex	Potency & Assay	Nationwide
22 Jan 2014Drug	CLASS II	ARIPiprazole Tablet, 15 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	ARIPiprazole Tablet, 2 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
13 Mar 2013Drug	CLASS II	Abilify (aripiprazole) Tablets, 30 mg recalled by Bristol Myers SquibbAbilify	Bristol Myers Squibb Manufacturing	Manufacturing (CGMP) Deviations	CA, LA, TN

Should you stop taking Aripiprazole?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.