Yeonsu, N/A, Korea (the Republic of)
Samsung Bioepis Co., Ltd. recalls
1 recall recorded since 2018, most recently on 10 October 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 10 October 2025
- Reason
- Lack of Assurance of Sterility.
- Distribution
- Distributed only to one warehouse in NJ. with no further distribution
- Initiated
- Voluntary: Firm initiated
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.