Recall archive / FDA drug enforcement
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured ... — FDA record D-0099-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 10, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Lack of Assurance of Sterility.
- Classification
- Class II
- Recalling firm
- Samsung Bioepis Co., Ltd.
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Agency-reported status
- Ongoing
- Source record identifier
- D-0099-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: F2505017, Expiry: 24-Jan-2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed only to one warehouse in NJ. with no further distribution
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 5, 2025
- Recall initiation date
- Oct 10, 2025
- Center classification date
- Oct 24, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.