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 Kore

FDA recall notice · announced November 5, 2025 · Samsung Bioepis Co

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Distributed only to one warehouse in NJ. with no further distribution
Lot/code information: Lot: F2505017, Expiry: 24-Jan-2027
Quantity: 5,518 packs (11,036 Syringes) 2 syringes/carton)
Status: Ongoing
Products in this recall event:
- 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 (D-0099-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.