HADLIMA — Class II drug recall D-0099-2026
Ongoing recall by Samsung Bioepis Co., Ltd., reported 2025-11-05, distributed in NJ. Lack of Assurance of Sterility.
| Recall number | D-0099-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Samsung Bioepis Co., Ltd., Yeonsu, N/A, Korea (the Republic of) |
| Recall initiated | 2025-10-10 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | NJ |
| Reason classes | sterility |
| NDC | 78206-0183-01 |
| Lot numbers | F2505017 |
| Expiration dates | 2027-01-24 |
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 for recall
Lack of Assurance of Sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0099-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.