FDAHealthOctober 10, 2025
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 subsidiary of ORGANON & Co, Jersey
⚠️ Lack of Assurance of Sterility.
Is this relevant to me?
- Geography
- NJ
- Source agency
- FDA
- Category
- Health
- Published
- October 10, 2025
Distributed only to one warehouse in NJ. with no further distribution
What's affected?
- 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.
- Lot code
- F2505017
Additional details
Lot: F2505017, Expiry: 24-Jan-2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,518 packs (11,036 Syringes) 2 syringes/carton).
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