Drug recall D-0767-2026
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
Lots and codes
Lot: 8494000002, Exp 7/31/28
Recall details
- Recalling firm
- Regeneron Pharmaceuticals Inc, Tarrytown, NY
- Quantity
- 21,353 vials
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 28, 2026
Related products
- Libtayo – drug information
- NDC 61755-008 Libtayo · Cemiplimab 50 mg/mL · Regeneron Pharmaceuticals, Inc.