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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.,…

Lack of Assurance of Sterility

Class II Medicine & devices FDA August 26, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Regeneron Pharmaceuticals Inc — Tarrytown, NY
Severity
Class II — moderate
Reported
August 26, 2026
Quantity
21,353 vials
Recall number
D-0767-2026
Status
Ongoing
Source
FDA

Where it went

USA Nationwide

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