Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Livalo (pitavatstatin) tablets Recalled by Kowa Pharmaceuticals America Due to Presence of foreign tablets/capsules
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Kowa Pharmaceuticals America directly.
Affected Products
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
Quantity: 5,328 Bottles
Why Was This Recalled?
Presence of foreign tablets/capsules
Where Was This Sold?
This product was distributed to 3 states: OH, PA, TX
About Kowa Pharmaceuticals America
Kowa Pharmaceuticals America has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report