Montgomery, AL, United States
Kowa Pharmaceuticals America recalls
1 recall recorded since 2018, most recently on 24 February 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class III Drugs
- Recall started
- 24 February 2025
- Reason
- Presence of foreign tablets/capsules
- Distribution
- PA, OH, and TX
- Initiated
- Voluntary: Firm initiated
- 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 Pharmaceuti
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.