FDA Drugs recall ·
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only… recall
Read the official FDA notice ↗
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
Why was it recalled?
Presence of foreign tablets/capsules
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 3231300, Exp 8/2027
Distribution
PA, OH, and TX
States: Ohio Pennsylvania Texas
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0258-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.