Second Tokushima Factory, Otsuka Pharmaceutical Abilify Recall

Why it was recalled

Cross Contamination with Other Products

Product description

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

Lot numbers, UPCs & expiration codes

Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025

Where it was sold

USA nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0466-2024
Classification: Class III
Status: Ongoing
Recall initiated: Apr 9, 2024
FDA report date: May 1, 2024
Quantity: 108,192/30 count bottles or 7 count blister packs
Recall type: Voluntary: Firm initiated
Recalling firm: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Original FDA data

Every field from FDA enforcement report D-0466-2024, exactly as published.

Show all FDA fields

City: Tokushima
Status: Ongoing
Country: Japan
Event ID: 94382
Address: 224-18
Address (line 2): Kawauchi-Cho
Code information: Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025
Report date: May 1, 2024
Product type: Drugs
Recall number: D-0466-2024
Classification: Class III
Recalling firm: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Product quantity: 108,192/30 count bottles or 7 count blister packs
Reason for recall: Cross Contamination with Other Products
Voluntary / mandated: Voluntary: Firm initiated
Product description: Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Distribution pattern: USA nationwide.
Recall initiation date: Apr 9, 2024
Initial firm notification: Letter
Center classification date: Apr 23, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0466-2024, published May 1, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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