Regeneron Pharmaceuticals Inc recalls Libtayo
- Recalling company
- Regeneron Pharmaceuticals Inc
- 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
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 28, 2026
- Reported
- Aug 26, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 21,353 vials
- Lot / codes
- Lot: 8494000002, Exp 7/31/28
- Company location
- Tarrytown, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0767-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0767-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.