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Libtayo (cemiplimab-rwlc) Injection recall

Regeneron Pharmaceuticals Inc recalled Libtayo (cemiplimab-rwlc) Injection on August 26, 2026 because of lack of Assurance of Sterility. It was sold nationwide.

Why it was recalled

Lack of Assurance of Sterility

What's recalled

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

Quantity: 21,353 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Regeneron Pharmaceuticals Inc, Tarrytown, NY
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
USA Nationwide
Status
Ongoing
Recall number
D-0767-2026
Source
U.S. Food and Drug Administration

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