Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits
Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issues are limited to labeling errors such as misspelling and missing storage instructions.
Plain-English summary
Otsuka Pharmaceutical Development & Commercialization, Inc. is recalling 4,738 physician sample kits of treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA 400-mg for extended release injectable suspension. The kits contain two packs of Abilify Tablets 10 mg (14-day supply) and one Abilify Maintena Vial Kit. The affected lots are 7F92YUD3H1A/ACS1616B (EXP 31-Jul-2019) and F92YUD3H1A/ACS0118C (EXP 30-Jun-2020). The product was distributed nationwide in the US.
The recall was initiated because the physician sample kits are mislabeled. Specifically, the product name is misspelled, storage instructions are missing, and the contents of the kits may be incorrectly labeled on the outer packaging of the co-packaged kit. The FDA has classified this as a Class III recall, indicating that the labeling errors are unlikely to cause adverse health consequences.
Physicians and healthcare providers who have received these sample kits should stop using them and contact Otsuka for instructions on how to return the product. Patients who have already received prescriptions from these kits should consult their healthcare provider for guidance on their medication.
The recalled product
- 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
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 4,738
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: 7F92YUD3H1A/ACS1616B
- EXP 31-Jul-2019
- F92YUD3H1A/ACS0118C
- EXP 30-Jun-2020.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Otsuka Pharmaceutical Development & Commercialization, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Otsuka Pharmaceutical Development & Commercialization, Inc.
See all →- LowOtsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits
FDA (Drugs) · 2018-10-10
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