Notice names this product. Regeneron Pharmaceuticals’s Libtayo (cemiplimab-rwlc) Injection is named in FDA Class II recall D-0767-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Lack of Assurance of Sterility Identifying details: Lot: 8494000002, Exp 7/31/28. Units affected: 21,353 vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Lack of Assurance of Sterility
Company / brand: Regeneron Pharmaceuticals recalls
Affected product: Libtayo (cemiplimab-rwlc) Injection recall status
Official ID D-0767-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.