Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of foreign tablets/capsules
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
- Recalling firm
- Kowa Pharmaceuticals America
- NDC code
- 66869-404-90
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0258-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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