HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx...
FDA Recall #D-0099-2026 — Class II — October 10, 2025
Product Description
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.
Recalling Firm
Samsung Bioepis Co., Ltd. — Yeonsu, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,518 packs (11,036 Syringes) 2 syringes/carton)
Distribution
Distributed only to one warehouse in NJ. with no further distribution
Code Information
Lot: F2505017, Expiry: 24-Jan-2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated