Samsung Bioepis Co., Ltd. recalls HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for
Recalled November 5, 2025 · FDA recall D-0099-2026 · Samsung Bioepis
Hazard
Lack of Assurance of Sterility. · FDA Class II
Units
5,518 packs (11,036 Syringes) 2 syringes/carton)
Sold at
Distributed only to one warehouse in NJ. with no further distribution
Description
Lack of Assurance of Sterility.
Product
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 by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
Manufacturer(s)
Samsung Bioepis Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →