HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL
Recalled by Samsung Bioepis Co., Ltd.
Drug recall
Samsung Bioepis Co., Ltd.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Samsung Bioepis Co., Ltd. has recalled HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on November 5, 2025 and was initiated on October 10, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, with approximately 5,518 packs (11,036 Syringes) 2 syringes/carton) affected. The company behind the recall is Samsung Bioepis Co., Ltd., based in Yeonsu, N/A. The FDA describes the product as: “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, N…”
Why was HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL recalled?
According to the FDA, the stated reason for the recall is: “Lack of Assurance of Sterility.” In plain terms, this recall relates to a sterility or contamination concern.
Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.
What should you do?
If you think you may have bought HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, compare it against the product description and identifying codes (Lot: F2505017, Expiry: 24-Jan-2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Samsung Bioepis Co., Ltd. or your local health authority.
About this recall
This recall was distributed in N/A. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- November 5, 2025
- Recall started
- October 10, 2025
- Distributed in
- N/A
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL recalled?+
According to the FDA: Lack of Assurance of Sterility.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0099-2026. Information last synced from the FDA on July 6, 2026.