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Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharm...

FDA Recall #D-0466-2024 — Class III — April 9, 2024

Recall #D-0466-2024 Date: April 9, 2024 Classification: Class III Status: Ongoing

Product Description

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

Reason for Recall

Cross Contamination with Other Products

Recalling Firm

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — Tokushima, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

108,192/30 count bottles or 7 count blister packs

Distribution

USA nationwide.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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