Samsung Bioepis Co., Ltd.
Samsung Bioepis Co., Ltd. appears in FDA public data with 1 recall, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0099-2026, Class II) was initiated on October 10, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0099-2026 | Class II | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx on | October 10, 2025 |