⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Samsung Bioepis Co., Ltd.: HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a sub

DrugsSource: FDA (drug) · Date: 2025-11-05

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Samsung Bioepis Co., Ltd.
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 / hazard
Lack of Assurance of Sterility.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distributed only to one warehouse in NJ. with no further distribution
Recall initiated
2025-10-10
Code info
Lot: F2505017, Expiry: 24-Jan-2027
Product quantity
5,518 packs (11,036 Syringes) 2 syringes/carton)
Voluntary mandated
Voluntary: Firm initiated
City
Yeonsu
State
N/A
Country
Korea (the Republic of)
Event id
97710
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