Libtayo Injection
FDA Recall NDC 61755-008
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Libtayo (NDC 61755-008). A significant event, classified as Class II, was initiated on Jul 28, 2026 by Regeneron Pharmaceuticals, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Jul 28, 2026
Aug 26, 2026
21,353 vials
Recall Profile & Regulatory Data
Event ID
99523
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Regeneron Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: 8494000002, Exp 7/31/28
Affected Packages Involved in this Recall
61755-008-01Product
8494000002Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
