Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross Contamination with Other Products
What was recalled
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Recalling firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
NDC code
59148-007-13
Origin
N/A, Japan
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0466-2024
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.