Recall D-0767-2026

US Class II Ongoing · initiated 2026-07-28

Recalling firm

Regeneron Pharmaceuticals Inc, NY

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

Reason for recall

Lack of Assurance of Sterility

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