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Class IIOngoing

Regeneron Pharmaceuticals Inc recalls Libtayo (cemiplimab-rwlc) Injection

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Regeneron Pharmaceuticals Inc
Reason
Lack of Assurance of Sterility
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
USA Nationwide
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99523…

Products

  1. 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

    Codes/lots: Lot: 8494000002, Exp 7/31/28Quantity: 21,353 vialsRecall no. D-0767-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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