Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50… was recalled on July 28, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility.
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
Lot: 8494000002, Exp 7/31/28
Units affected: 21,353 vials
Where it was sold: USA Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Lack of Assurance of Sterility
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Regeneron Pharmaceuticals Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
View official notice →The toys’ zipper contains levels of lead that exceed the standard set in the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health issues.
The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Be the first to know when products like this are recalled. Free weekly digest, unsubscribe anytime.