Regeneron Libtayo injection recall: Lack of sterility assurance risk
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.
Stop using this now
Lack of Assurance of Sterility
What happened, in plain English
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. Read more at govinfonow.com/recall/692891-regeneron-libtayo-injection-recall-lack-of-sterility-assurance-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/692891-regeneron-libtayo-injection-recall-lack-of-sterility-assurance-risk · Updated September 14, 2026 · FDA enforcement record: FDA #D-0767-2026
Cite this page
“Regeneron Libtayo injection recall: Lack of sterility assurance risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692891-regeneron-libtayo-injection-recall-lack-of-sterility-assurance-risk. Based on FDA recall #D-0767-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0767-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Patients prescribed Libtayo injections are affected. Those with the specific lot number 8494000002 and expiration date 7/31/28 are at highest risk.
How to tell if you have this one
Check for the lot number 8494000002 on the vial label. The expiration date is July 31, 2028. This product is only available through prescription.
- Brand
Regeneron- Category
Drug
What to do — step by step
Stop using it now
Immediately discard the Libtayo injection vial if it has lot number 8494000002.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Discard the vial immediately and contact your healthcare provider for alternative treatment.
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Where this comes from
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.
- Official source: FDA Recall #D-0767-2026 (July 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0767-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.