Kowa Pharmaceuticals America recalls Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 US…

Recall date

February 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0258-2025

FDA classification

Class III

Brand / firm

Kowa Pharmaceuticals America

Sold / distributed

PA, OH, and TX

Why it was recalled

Presence of foreign tablets/capsules

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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