Warning
Samsung Bioepis Co. Recalls HADLIMA (adalimumab-bwwd) injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0099-2026Drug / Pharmaceutical
Samsung Bioepis Co. Recalls HADLIMA (adalimumab-bwwd) injection
Samsung Bioepis Co., Ltd. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Distributed only to one warehouse in NJ. with no further distribution
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Samsung Bioepis Co., Ltd. initiated the recall on October 10, 2025 affecting 5,518 packs (11,036 Syringes) 2 syringes/carton). Lack of Assurance of Sterility. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Samsung Bioepis Co., Ltd. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.