Samsung Bioepis Co., Ltd. 2025-11-05 Health serious FDA
Health · FDA · Recall #FDA-D-0099-2026
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per… Recall
Issued November 5, 2025 · Samsung Bioepis Co., Ltd.
In November 2025, Samsung Bioepis Co., Ltd. recalled the HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility.
What you should do
- 1 Stop using HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Samsung Bioepis Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Samsung Bioepis Co., Ltd.
- Category
- Health
- Recall date
- November 5, 2025
- Units affected
- Not reported
- Sold at
- Distributed only to one warehouse in NJ. with no further distribution
- Recall number
- FDA-D-0099-2026
- Made in
- Korea (the Republic of)
- Issuing agency
- FDA
In context
- Samsung Bioepis Co., Ltd. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.