October 2025 FDA Recall Drug by Samsung Bioepis Co., Ltd.
D-0099-2026 - Lack of Assurance of Sterility.

This Class II drug recall was voluntarily initiated by Samsung Bioepis Co., Ltd. on October 10, 2025 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed in Distributed only to one warehouse in NJ. with no further distribution and the recall is currently ongoing.

Recall Number: D-0099-2026

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2025
Reported
11-05-2025
Quantity
5,518 packs (11,036 Syringes) 2 syringes/carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97710
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Samsung Bioepis Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed only to one warehouse in NJ. with no further distribution
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot: F2505017, Expiry: 24-Jan-2027