# FDA recall D-0018-2019

> **Otsuka Pharmaceutical Development & Commercialization, Inc.** · Class III · drug recall initiated 2018-09-17.

## 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.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0018-2019
- **Recalling firm:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2018-10-10
- **Termination date:** 2022-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2019

## Citation

> AI Analytics. FDA recall D-0018-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0018-2019. Source: US FDA. Licensed CC0.

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