Class IIICompleted

Livalo (pitavatstatin) tablets recall

FDA recall D-0258-2025 · initiated Feb 24, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Presence of foreign tablets/capsules

Details

Product: Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case
Recalling company: Kowa Pharmaceuticals America
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: PA, OH, and TX
Initiated: Feb 24, 2025
FDA report date: Mar 19, 2025

This recall is linked to a product we cover: Livalo →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0258-2025 ↗

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