Recalls / Class III
Class IIID-0258-2025
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
- Brand name
- Livalo
- Generic name
- Pitavastatin Calcium
- Active ingredient
- Pitavastatin Calcium
- Route
- Oral
- NDCs
- 66869-104, 66869-204, 66869-404
- FDA application
- NDA022363
- Affected lot / code info
- Lot#: 3231300, Exp 8/2027
Why it was recalled
Presence of foreign tablets/capsules
Recalling firm
- Firm
- Kowa Pharmaceuticals America
- Manufacturer
- Kowa Pharmaceuticals America, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 530 Industrial Park Blvd, Montgomery, Alabama 36117-5543
Distribution
- Quantity
- 5,328 Bottles
- Distribution pattern
- PA, OH, and TX
Timeline
- Recall initiated
- 2025-02-24
- FDA classified
- 2025-03-07
- Posted by FDA
- 2025-03-19
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0258-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.