CLASS III Drug recall · Reported 10 Oct 2018 · FDA Enforcement Report
treatNOW Abilify (aripiprazole) and Abilify Maintena recalled
Otsuka Pharmaceutical Development & Commercialization is recalling treatNOW Abilify (aripiprazole) and Abilify Maintena (aripiprazole) 400MG for extended, distributed nationwide in the US. The recall was initiated on 17 Sep 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0017-2019
- FDA event ID
- 81020
- Recalling firm
- Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Sep 2018
- FDA classified
- 12 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Sep 2018 | Recall initiated by company | |
| 10 Oct 2018 | Published in enforcement report | +23 days |
| 12 Oct 2018 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lots: 7F92YUD3H1A/AIS1017B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81020This product is part of a recall event; the main page for the event is treatNOW Abilify (aripiprazole) / Abilify Maintena 400-mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | treatNOW Abilify (aripiprazole) / Abilify Maintena 400-mg recalled | Otsuka Pharmaceutical Development & Commercialization | Labeling Errors | Nationwide |
More recalls from Otsuka Pharmaceutical Development & Commercialization
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | treatNOW Abilify (aripiprazole) / Abilify Maintena 400-mg recalled | Otsuka Pharmaceutical Development & Commercialization | Labeling Errors | Nationwide |
Other Treatnow Abilify (aripiprazole recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | treatNOW Abilify (aripiprazole) / Abilify Maintena 400-mg recalled | Otsuka Pharmaceutical Development & Commercialization | Labeling Errors | Nationwide |