Regeneron Pharmaceuticals Inc — 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., T

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Lack of Assurance of Sterility

Provider: FDA — drug enforcement reference
Source observed: 8/26/2026, 12:00:00 AM UTC
Source updated: 8/26/2026, 12:00:00 AM UTC
Location: Tarrytown, NY, US
hazard: Lack of Assurance of Sterility
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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
distribution: USA Nationwide
manufacturer: Regeneron Pharmaceuticals Inc
recall number: D-0767-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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