FDA Drugs recall ·
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL… recall
- Recall number
- D-0099-2026
- Date
- (initiated October 10, 2025)
- Company / brand
- Samsung Bioepis Co., Ltd.
76 Songdogyoyuk-Ro, Yeonsu, N/A, Korea (the Republic of) - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Lack of Assurance of Sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: F2505017, Expiry: 24-Jan-2027
Distribution
Distributed only to one warehouse in NJ. with no further distribution
States: New Jersey
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0099-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.