FDAFDA · Food and drugs·Recall number D-0258-2025
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
Published March 19, 2025 · Recall initiated: February 24, 2025
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of foreign tablets/capsules
What to do
Voluntary: Firm initiated
Recall details
- Brand
- LIVALO
- Manufacturer
- Kowa Pharmaceuticals America
- Distributor
- PA, OH, and TX
- UPC
- 0366869204905
- Lot
- Lot#: 3231300, Exp 8/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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