Reported May 1, 2024 · Ongoing

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

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · 224-18 · Tokushima, N/A · N/A

Is this the product you have?

  • Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Lot codes and dates
    • Lot # AKS00623A
    • Exp 01/31/2026
    • AKS00322A
    • Exp 02/28/2025
Amount recalled
108,192/30 count bottles or 7 count blister packs

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Cross Contamination with Other Products

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.