Reported Nov 5, 2025 · Ongoing
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured…
Samsung Bioepis Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Samsung Bioepis Co., Ltd. · 76 Songdogyoyuk-Ro · Yeonsu, N/A · N/A
Is this the product you have?
- HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only
- Manufactured forOrganon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302
- Manufactured bySAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01
- Lot codes and dates
- LotF2505017
- Expiry24-Jan-2027
- Amount recalled
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
Where it was sold
Why it was recalled
Lack of Assurance of Sterility.
This product could cause temporary or reversible health problems — stop using it.
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