Regeneron Pharmaceuticals Inc recalls Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial,
Recalled August 26, 2026 · FDA recall D-0767-2026 · Regeneron Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
21,353 vials
Sold at
USA Nationwide
Description
Lack of Assurance of Sterility
Product
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
Manufacturer(s)
Regeneron Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →