Samsung Bioepis recalls

FDA enforcement reports naming Samsung Bioepis Co., Ltd. as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Nov 5, 2025

Severity

Nov 5, 2025HADLIMA (adalimumab-bwwd) injection, 40mg/0Drug · Samsung Bioepis Co., Ltd.Lack of Assurance of Sterility.Class II