Samsung Bioepis Co., Ltd.

Yeonsu, N/A, Korea (the Republic of)

1

Total Recalls

0

Class I Recalls

1

Ongoing Recalls

Recalls by Samsung Bioepis Co., Ltd.

FDA Drug Class II Ongoing

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured

October 10, 2025 Samsung Bioepis Co., Ltd. 5,518 packs (11,036 Syringes) 2 syringes/carton) units