Drug recall D-0099-2026

Class II Ongoing reported Nov 5, 2025

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.

Lots and codes

Lot: F2505017, Expiry: 24-Jan-2027

Recall details

Recalling firm
Samsung Bioepis Co., Ltd., Yeonsu, N/A
Quantity
5,518 packs (11,036 Syringes) 2 syringes/carton)
Distribution
Distributed only to one warehouse in NJ. with no further distribution
Type
Voluntary: Firm initiated
Recall initiated
October 10, 2025

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