Recall Enforment Report D-0099-2026

Drug Recall Enforcement Report Class II voluntary initiated by Samsung Bioepis Co., Ltd., originally initiated on 10-10-2025 for 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. The product was recalled due to 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.

Field Name	Field Value
Event ID	97710 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0099-2026 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Distributed only to one warehouse in NJ. with no further distribution What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	Lack of Assurance of Sterility. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5,518 packs (11,036 Syringes) 2 syringes/carton) Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	11-05-2025
Recall Initiation Date	10-10-2025 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Samsung Bioepis Co., Ltd.
Code Info	Lot: F2505017, Expiry: 24-Jan-2027 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	78206-183-99; 78206-183-01; 78206-184-99; 78206-184-01; 78206-185-99; 78206-185-01; 78206-186-99; 78206-186-01; 78206-187-99; 78206-187-01; 78206-187-58; 78206-187-59
Status	Ongoing

Recalled Products