HADLIMA injection recalled over sterility concerns
- Recall date
- October 10, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Samsung Bioepis Co., Ltd. recalls HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured fo…
- Recall number
- D-0099-2026
- FDA classification
- Class II
- Brand / firm
- Samsung Bioepis Co., Ltd.
- Sold / distributed
- Distributed only to one warehouse in NJ. with no further distribution
Why it was recalled
Lack of Assurance of Sterility.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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