Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended Recalled by Otsuka Pharmaceutical Development & Commercialization, Inc. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Otsuka Pharmaceutical Development & Commercialization, Inc. directly.
Affected Products
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
Quantity: 4738 kits
Why Was This Recalled?
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report