treatNOW ABILIFY — Class III drug recall D-0017-2019
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-0017-2019 |
|---|---|
| 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 | 17,325 kits |
| Reason classes | labeling |
| Lot numbers | 7F92YUD3H1A/AIS1017B, 7F92YUD3H1A/AIS1017C |
| Expiration dates | 2020-06-30 |
Product
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
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-0017-2019. 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.