Kowa Pharmaceuticals America

FDA Regulatory Profile

Kowa Pharmaceuticals America appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0258-2025, Class III) was initiated on February 24, 2025.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0258-2025Class IIILivalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. CincFebruary 24, 2025