Samsung Bioepis Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0099-2026Class IIHADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx onOctober 10, 2025