treatNOW ABILIFY — Class III drug recall D-0018-2019

Terminated recall by Otsuka Pharmaceutical Development & Commercialization, Inc., reported 2018-10-10, distributed nationwide. Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product n

Recall number	`D-0018-2019`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
Recall initiated	2018-09-17
Classified	2018-10-12
Reported by FDA	2018-10-10
Terminated	2022-03-09
Distributed	Nationwide (US)
Quantity	4,738 kits
Reason classes	labeling
Lot numbers	`7F92YUD3H1A/ACS1616B`, `F92YUD3H1A/ACS0118C`
Expiration dates	`2019-07-31`, `2020-06-30`

Product

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

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0018-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.