Class IIReported 2025-11-05

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.

Reason for Recall

Lack of Assurance of Sterility.

Recall Number

D-0099-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-10

Reported

2025-11-05

Distribution

Distributed only to one warehouse in NJ. with no further distribution

Code Info

Lot: F2505017, Expiry: 24-Jan-2027

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.