Abilify (aripiprazole) recall
FDA recall D-0468-2024 · initiated Apr 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalled Abilify (aripiprazole) in Apr 2024 — an FDA Class III recall (D-0468-2024) because Cross Contamination with Other Products.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross Contamination with Other Products
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
- Recalling company
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Apr 9, 2024
- FDA report date
- May 1, 2024
Frequently asked
- Was Abilify (aripiprazole) recalled?
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalled Abilify (aripiprazole) in Apr 2024 — an FDA Class III recall (D-0468-2024) because Cross Contamination with Other Products. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Abilify (aripiprazole) recalled?
- Per the FDA enforcement record, the reason for recall D-0468-2024 was: Cross Contamination with Other Products
- Is a recalled Abilify (aripiprazole) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Abilify (aripiprazole) are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # AMS00223A, Exp 07/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0468-2024.