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.

This recall is currently active, issued November 5, 2025. It was issued by Samsung Bioepis Co., Ltd..

Company

Samsung Bioepis Co., Ltd.

Recall Initiated

October 10, 2025

Posted

November 5, 2025

Recall Number

D-0099-2026

Voluntary / Mandated

Voluntary: Firm initiated

Quantity

5,518 packs (11,036 Syringes) 2 syringes/carton)

Firm Location

Yeonsu, Korea (the Republic of)

Official Source

View on FDA website ↗