Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial,…
Regeneron Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Regeneron Pharmaceuticals Inc · 777 Old Saw Mill River Rd · Tarrytown, NY · 10591-6717
Is this the product you have?
- Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only
- Manufactured byRegeneron Pharmaceuticals, Inc., Tarrytown, NY 10591
- Marketed byRegeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
- Lot codes and dates
- Lot
8494000002Exp 7/31/28
- Lot
- Amount recalled
- 21,353 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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