Recalls / Class II
Class IID-0099-2026
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.
- Brand name
- Hadlima
- Generic name
- Adalimumab-bwwd
- Active ingredient
- Adalimumab
- Route
- Subcutaneous
- NDCs
- 78206-184, 78206-183, 78206-185, 78206-186, 78206-187
- FDA application
- BLA761059
- Affected lot / code info
- Lot: F2505017, Expiry: 24-Jan-2027
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- Samsung Bioepis Co., Ltd.
- Manufacturer
- Organon LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 76 Songdogyoyuk-Ro, N/A, Yeonsu, N/A N/A, Korea (the Republic of)
Distribution
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Distribution pattern
- Distributed only to one warehouse in NJ. with no further distribution
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-10-24
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0099-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.