Drug Recall: 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
Samsung Bioepis Co., Ltd. · October 10, 2025
Reason for Recall
Lack of Assurance of Sterility.
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.
Distribution
Distributed only to one warehouse in NJ. with no further distribution
States Affected
IN, NJ
Quantity Affected
5,518 packs (11,036 Syringes) 2 syringes/carton)
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0099-2026
Status: ongoing
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