FDAFDA · Food and drugs·Recall number D-0767-2026
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
Published August 26, 2026 · Recall initiated: July 28, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LIBTAYO
- Manufacturer
- Regeneron Pharmaceuticals Inc
- Distributor
- USA Nationwide
- Lot
- Lot: 8494000002, Exp 7/31/28
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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