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.
Reported: November 5, 2025 Initiated: October 10, 2025 #D-0099-2026
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.
Reason for Recall
Lack of Assurance of Sterility.
Details
- Recalling Firm
- Samsung Bioepis Co., Ltd.
- Units Affected
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Distribution
- Distributed only to one warehouse in NJ. with no further distribution
- Location
- Yeonsu, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Samsung Bioepis Co., Ltd.. Units affected: 5,518 packs (11,036 Syringes) 2 syringes/carton).
Why was this product recalled? ▼
Lack of Assurance of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2025. Severity: Moderate. Recall number: D-0099-2026.
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