Quick answers
- What is Aripiprazole used for?
- The FDA-approved label (Abilify, Otsuka America Pharmaceutical, Inc., January 29, 2025) says: “ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Aripiprazole have a boxed warning?
- Yes. The FDA label for Abilify has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Aripiprazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aripiprazole been recalled?
- FDA enforcement reports list 18 recalls of products of this medicine; the newest started May 27, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Aripiprazole?
- 47 companies list prescription products of Aripiprazole in the FDA NDC Directory, including Bryant Ranch Prepack, ScieGen Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc..
What Aripiprazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for …
— FDA label: Abilify, Otsuka America Pharmaceutical, Inc., effective January 29, 2025. Read the full label on DailyMed →
The FDA has 116 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
115 of 116 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, orally disintegrating · Solution · Film, soluble · Injection, suspension, extended release |
|---|---|
| Route | Oral · Intramuscular |
| Prescription products | 269 in the FDA NDC Directory |
| Brand names | Abilify, Opipza, Abilify Asimtufii |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| aripiprazole 1 mg/mL solution | Generic | $0.3955 per mL |
| aripiprazole 10 mg tablet | Generic | $0.1186–$2.42 per tablet 30 packages, lowest to highest |
| aripiprazole 10 mg tablet | Brand: Abilify | $18.62 per tablet |
| aripiprazole 10 mg tablet, orally disintegrating | Generic | $2.42 per tablet |
| aripiprazole 15 mg tablet | Generic | $0.1338–$1.81 per tablet 29 packages, lowest to highest |
| aripiprazole 15 mg tablet | Brand: Abilify | $18.65 per tablet |
| aripiprazole 15 mg tablet, orally disintegrating | Generic | $1.81 per tablet |
| aripiprazole 2 mg tablet | Generic | $0.1206 per tablet |
| aripiprazole 2 mg tablet | Brand: Abilify | $18.67 per tablet |
| aripiprazole 20 mg tablet | Generic | $0.1818 per tablet |
| aripiprazole 20 mg tablet | Brand: Abilify | $26.25 per tablet |
| aripiprazole 30 mg tablet | Generic | $0.1828 per tablet |
| aripiprazole 30 mg tablet | Brand: Abilify | $26.23 per tablet |
| aripiprazole 5 mg tablet | Generic | $0.1165 per tablet |
| aripiprazole 5 mg tablet | Brand: Abilify | $18.68 per tablet |
| aripiprazole 720 mg/2.4 mL injection, suspension, extended release | Brand: Abilify Asimtufii | $1,786.43 per mL |
| aripiprazole 960 mg/3.2 mL injection, suspension, extended release | Brand: Abilify Asimtufii | $1,781.74 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack16 products
- ScieGen Pharmaceuticals, Inc.14 products
- Camber Pharmaceuticals, Inc.13 products
- Remedyrepack Inc.13 products
- Solco Healthcare U.S., LLC12 products
- XLCare Pharmaceuticals, Inc.12 products
- Dr.Reddys Laboratories Inc12 products
- A-S Medication Solutions11 products
- Aurobindo Pharma Limited9 products
- Coupler LLC8 products
- Otsuka America Pharmaceutical, Inc.8 products
- Alembic Pharmaceuticals Limited8 products
- Alembic Pharmaceuticals Inc.8 products
- NorthStar RxLLC7 products
- Amneal Pharmaceuticals LLC7 products
- Major Pharmaceuticals7 products
- Proficient Rx LP6 products
- Accord Healthcare Inc.6 products
- Unichem Pharmaceuticals (USA), Inc.6 products
- American Health Packaging6 products
- Ascend Laboratories, LLC6 products
- Exelan Pharmaceuticals Inc.6 products
- Torrent Pharmaceuticals Limited6 products
- Ajanta Pharma USA Inc.6 products
- AvPAK6 products
- Macleods Pharmaceuticals Limited6 products
- Preferred Pharmaceuticals Inc.5 products
- Quallent Pharmaceuticals Health LLC4 products
- Direct_Rx4 products
- Square Pharmaceuticals Limited4 products
- NuCare Pharmaceuticals, Inc.4 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Carwin Pharmaceutical Associates, LLC3 products
- Dr. Reddy's Laboratories Inc.2 products
- Bionpharma Inc.2 products
- Viona Pharmaceuticals Inc2 products
- Apotex Corp.1 product
- Lannett Company, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Prefferred Pharmaceuticals Inc.1 product
- Advagen Pharma Ltd1 product
- Chartwell RX, LLC1 product
- Quagen Pharmaceuticals LLC1 product
- Unit Dose Solutions, Inc.1 product
- Atlantic Biologicals Corp.1 product
- VistaPharm, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021436 ABILIFY | Otsuka | November 15, 2002 | 41, latest January 22, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| NDA216655 OPIPZA | Xiamen LP Pharm Co | July 22, 2024 | 1, latest March 20, 2025 2025: Labeling |
| NDA217006 ABILIFY ASIMTUFII | Otsuka | April 27, 2023 | 2, latest March 28, 2025 2025: Efficacy · 2025: Labeling |
Generic approvals (26)
- ANDA201519Torrent · April 28, 2015
- ANDA202101Alembic · April 28, 2015
- ANDA202102Alembic · April 28, 2015
- ANDA205064Hetero Labs Ltd V · April 28, 2015
- ANDA203906Amneal Pharms · August 14, 2015
- ANDA204171Lannett Co Inc · August 14, 2015
- ANDA204094Apotex · September 30, 2015
- ANDA203908Aurobindo Pharma · October 8, 2015
- ANDA204838Amneal Pharms · June 17, 2016
- ANDA206174Ajanta Pharma Ltd · September 12, 2016
- ANDA206383Sciegen Pharms · September 29, 2016
- ANDA204111Macleods Pharms · October 7, 2016
- ANDA206251Accord Hlthcare · December 7, 2016
- ANDA205363Prinston Inc · December 4, 2017
- ANDA202547Orbion Pharms · December 11, 2017
- ANDA207240Sciegen Pharms · April 18, 2018
- ANDA090165Square Pharms · August 28, 2018
- ANDA210479Aurobindo Pharma Ltd · January 29, 2019
- ANDA207105Alkem Labs Ltd · February 21, 2019
- ANDA212870Vistapharm LLC · December 26, 2019
- ANDA203025Unichem · December 1, 2021
- ANDA215595Chartwell Rx · October 25, 2022
- ANDA216351Rubicon Research · October 27, 2022
- ANDA216150Hetero Labs Ltd III · November 1, 2023
- ANDA215582Quagen · October 22, 2025
- ANDA216208Aurobindo Pharma · February 18, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 27, 2026 · Class II · Ongoing · D-0594-2026
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. — Ajanta Pharma USA Inc
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August 28, 2025 · Class II · Ongoing · D-0645-2025
Superpotent drug
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03 — Ascend Laboratories, LLC
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April 9, 2024 · Class III · Ongoing · D-0466-2024
Cross Contamination with Other Products
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
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April 9, 2024 · Class III · Ongoing · D-0468-2024
Cross Contamination with Other Products
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
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April 9, 2024 · Class III · Ongoing · D-0467-2024
Cross Contamination with Other Products
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc. — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
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April 9, 2024 · Class III · Ongoing · D-0469-2024
Cross Contamination with Other Products
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
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March 17, 2023 · Class II · Ongoing · D-0539-2023
Out of specification (OOS) for Spectroscopic Identification test by IR.
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05 — Ascend Laboratories, LLC
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February 7, 2023 · Class II · Terminated · D-0370-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0366-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 7; Manufactured for: Accord Healthcare, Inc., Durham — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0367-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durha — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0365-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durha — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0368-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0369-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durh — Accord Healthcare, Inc.
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January 26, 2022 · Class II · Terminated · D-0167-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03 — CARDINAL HEALTHCARE
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June 10, 2020 · Class II · Terminated · D-1341-2020
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 — Alembic Pharmaceuticals Limited
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January 19, 2018 · Class II · Terminated · D-0595-2018
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio — AMERICAN HEALTH PACKAGING
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January 10, 2018 · Class II · Terminated · D-0594-2018
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, — Hetero Labs, Ltd. - Unit III
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November 2, 2012 · Class II · Terminated · D-181-2013
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.
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 — Bristol Myers Squibb Manufacturing Company
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Abilify, Otsuka America Pharmaceutical, Inc., effective January 29, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →