FDA-Drug2026-08-26Class IIPROCESSING DEFECT
Regeneron Libtayo injection recalled for lack of sterility assurance
What this means
Regeneron is recalling one lot of Libtayo (cemiplimab-rwlc), an intravenous cancer treatment, because the manufacturer cannot guarantee the vials are sterile. This affects lot 8494000002, which expires July 31, 2028. About 21,353 vials are involved in the recall nationwide.
- Contact your healthcare provider or hospital if you received Libtayo from this lot
- Do not use vials from lot 8494000002 if you have them in storage
- Ask your provider about obtaining unaffected product or alternative treatment
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
21,353 vials
Manufactured in
777 Old Saw Mill River Rd, Tarrytown, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0767-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.