D-0099-2026Class II

Samsung Bioepis Co., Ltd.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-11-05

Distribution

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

Firm state

N/A

Product quantity

5,518 packs (11,036 Syringes) 2 syringes/carton)

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

Lack of Assurance of Sterility.

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.

Code / lot info

Lot: F2505017, Expiry: 24-Jan-2027

Other recalls SPEQ maps to Environmental Monitoring

2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.