FDAFDA · Food and drugs·Recall number D-0099-2026
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.
Published November 5, 2025 · Recall initiated: October 10, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Samsung Bioepis Co., Ltd.
- Distributor
- Distributed only to one warehouse in NJ. with no further distribution
- Lot
- Lot: F2505017, Expiry: 24-Jan-2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Korea (the Republic of)
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