The Recall Desk

Manufacturer

Samsung Bioepis Co., Ltd.

1 recall in our database name Samsung Bioepis Co., Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2025-11-05

Of the 1 recalls from Samsung Bioepis Co., Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Drugs)·D-0099-2026·2025-11-05

    Adalimumab prefilled syringes recalled for lack of sterility assurance

    Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.

    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.
    Category
    Drug
    Distribution
    1 state