Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HADLIMA (adalimumab-bwwd) injection Recalled by Samsung Bioepis Co., Ltd. Due to Lack of Assurance of Sterility.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Samsung Bioepis Co., Ltd. directly.
Affected Products
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.
Quantity: 5,518 packs (11,036 Syringes) 2 syringes/carton)
Why Was This Recalled?
Lack of Assurance of Sterility.
Where Was This Sold?
This product was distributed to 1 state: NJ
About Samsung Bioepis Co., Ltd.
Samsung Bioepis Co., Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report