Samsung Bioepis Co., Ltd.: Drug Recall
Recall #D-0099-2026 · 10/10/2025
Class II: Risk
Recall Details
- Recall Number
- D-0099-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Samsung Bioepis Co., Ltd.
- Status
- Ongoing
- Date Initiated
- 10/10/2025
- Location
- Yeonsu, N/A, Korea (the Republic of)
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
Reason for Recall
Lack of Assurance of Sterility.
Product Description
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.
Distribution Pattern
Distributed only to one warehouse in NJ. with no further distribution
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.