Samsung Bioepis Co., Ltd. recalls HADLIMA
- Recalling company
- Samsung Bioepis Co., Ltd.
- 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.
- Reason
- Lack of Assurance of Sterility.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 10, 2025
- Reported
- Nov 5, 2025
- Distribution
- Distributed only to one warehouse in NJ. with no further distribution
- Status
- Ongoing
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Lot / codes
- Lot: F2505017, Expiry: 24-Jan-2027
- Company location
- Yeonsu, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0099-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0099-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.