Official recall notice

FDA DrugClass IINotable

FDA Recall: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution

Recall date
2026-08-26
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility

Product description

Lack of Assurance of Sterility

Affected products

Lot: 8494000002, Exp 7/31/28

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