Regeneron recalls Libtayo (cemiplimab-rwlc) injections due to lack of sterility assurance. This could lead to infections if used improperly. Affected units have specific lot numbers and expiration dates.
Lack of Assurance of Sterility
Regeneron is recalling Libtayo injections because they may not be sterile, which could cause infections. This is a serious risk for patients receiving the medication.
The injections may not be sterile, meaning they could introduce harmful bacteria into the bloodstream during IV use. This poses a risk of infection, especially in patients with weakened immune systems.
Patients prescribed Libtayo injections are affected. Those with the specific lot number 8494000002 and expiration date 7/31/28 are at highest risk.
Check for the lot number 8494000002 on the vial label. The expiration date is July 31, 2028. This product is only available through prescription.
Immediately discard the Libtayo injection vial if it has lot number 8494000002.
No, the product may not be sterile and could cause infections. Do not use it.
Discard the vial immediately and contact your healthcare provider for alternative treatment.
Look for the lot number 8494000002 on the vial label and expiration date of July 31, 2028.
We’ve drafted a message you can send Regeneron to request your refund or repair — edit it as you like.
Subject: Recall D-0767-2026 — Regeneron Regeneron Hello, I own a Regeneron that is covered by recall D-0767-2026 from Regeneron. 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.
