FDA recall D-0099-2026

Samsung Bioepis Co., Ltd. · Class II · drug

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.

Reason for recall

Lack of Assurance of Sterility.

Distribution

Distributed only to one warehouse in NJ. with no further distribution

Key facts

Status
Ongoing
Initiation date
2025-10-10
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yeonsu, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2026