CLASS III ONGOING Drug recall · Reported 1 May 2024 · FDA Enforcement Report
Abilify (aripiprazole) recalled by Second Tokushima Factory
Second Tokushima Factory, Otsuka Pharmaceutical Co is recalling Abilify (aripiprazole), distributed nationwide in the US. The recall was initiated on 9 Apr 2024 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-0468-2024
- FDA event ID
- 94382
- Recalling firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co, Tokushima, N/A
- Brand
- Abilify
- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 9 Apr 2024
- FDA classified
- 23 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 9 Apr 2024 | Recall initiated by company | |
| 23 Apr 2024 | Classified by FDA | +14 days |
| 1 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Products
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Where it was distributed
USA nationwide.
Questions about this recall
Is Abilify (aripiprazole) recalled?
Yes. Second Tokushima Factory, Otsuka Pharmaceutical Co recalled Abilify (aripiprazole) on 9 Apr 2024. The recall is Class III and its status is Ongoing. Recall number D-0468-2024.
Why was it recalled?
Cross Contamination with Other Products
Which lots are affected?
Lot # AMS00223A, Exp 07/31/2025
Where was it sold?
USA nationwide.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Second Tokushima Factory, Otsuka Pharmaceutical Co
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
Other Aripiprazole recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole | Ajanta Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets, USP, 10 mg recalled by Ascend LaboratoriesAripiprazole | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |