Samsung Bioepis recalls HADLIMA (adalimumab-bwwd) injections due to lack of sterility assurance. This may cause infections. Affected units have specific lot numbers and expiry dates.
Lack of Assurance of Sterility.
Samsung Bioepis is recalling HADLIMA injections because they may not be sterile, which could lead to infections. This is a serious issue for people using the medication under a prescription.
The injections may not be sterile, which can cause infections in the body. This is a serious risk for people receiving the medication through injection.
People with a prescription for HADLIMA injections from the recalled lot numbers are affected. Those using the medication for autoimmune conditions like rheumatoid arthritis are most at risk.
Check the product label for the lot number F2505017 and expiry date 24-Jan-2027. The product is a 40mg/0.8 mL injection with 2 single-dose prefilled syringes per carton.
Look for the lot number F2505017 and expiry date 24-Jan-2027 on the product label.
The official recall states there is a risk of lack of sterility, so it is not safe to use the recalled product.
Check the product label for the lot number F2505017 and expiry date 24-Jan-2027.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Samsung Bioepis to request your refund or repair — edit it as you like.
Subject: Recall D-0099-2026 — Samsung Bioepis Samsung Bioepis Hello, I own a Samsung Bioepis that is covered by recall D-0099-2026 from Samsung Bioepis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
