Otsuka ABILIFY Sample Kits Mislabeled - Risk of Incorrect Use
Otsuka recalls physician sample kits of ABILIFY (aripiprazole) due to mislabeling. Product name misspelled, storage instructions missing, and contents incorrectly labeled. Consumers should check kit details and contact Otsuka for guidance.
Lower-risk 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.
Contact the company
What happened, in plain English
Otsuka is recalling physician sample kits of ABILIFY (aripiprazole) because the product name is misspelled, storage instructions are missing, and contents are incorrectly labeled. This could lead to incorrect use if someone relies on the mislabeled information. Read more at govinfonow.com/recall/39565-otsuka-abilify-sample-kits-mislabeled-risk-of-incorrect-use.
Source Summary by GovInfoNow · govinfonow.com/recall/39565-otsuka-abilify-sample-kits-mislabeled-risk-of-incorrect-use · Updated October 6, 2026 · FDA enforcement record: FDA #D-0018-2019
Cite this page
“Otsuka ABILIFY Sample Kits Mislabeled - Risk of Incorrect Use.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39565-otsuka-abilify-sample-kits-mislabeled-risk-of-incorrect-use. Based on FDA recall #D-0018-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0018-2019%22&limit=1).
Why it’s dangerous
The sample kits have a misspelled product name, missing storage instructions, and incorrect labeling of contents. This could lead to confusion about the medication's proper use, potentially causing incorrect administration.
Who’s affected
Physicians and healthcare providers who received the mislabeled sample kits. Those most at risk are individuals who might use the incorrect labeling to administer the medication.
How to tell if you have this one
Check for kits with the misspelled name 'Abilfy' instead of 'Abilify', missing storage instructions, and incorrect labeling of contents. Look for bar codes starting with VialKit-59148-10Tabs-02 and specific lot numbers.
- Brand
Otsuka- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the US
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0017-2019 | treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01; Lots: 7F92YUD3H1A/AIS1017B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020. | 17325 kits |
| D-0018-2019 | 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; Lots: 7F92YUD3H1A/ACS1616B, EXP 31-Jul-2019; F92YUD3H1A/ACS0118C, EXP 30-Jun-2020. | 4738 kits |
What to do — step by step
Check Kit Details
Verify the product name spelling, storage instructions, and contents labeling on the kit.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0018-2019 (September 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0018-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.