Benlysta Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 49401-101
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 Benlysta (NDC 49401-101). A significant event, classified as Class II, was initiated on Apr 21, 2025 by Glaxosmithkline Llc. The reported reason for this action was: "CGMP Deviations; potential temperature excursions due to transit delays"
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
April 2025 Class II Recall: CGMP Deviations; potential temperature excursions due to transit delays
Recall Number
Class II Ongoing
CGMP Deviations; potential temperature excursions due to transit delays
Apr 21, 2025
Jul 30, 2025
3 Vials
Recall Profile & Regulatory Data
Event ID
97110
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within the U.S - OH, VA, FL.
Product Description
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Batch or Lot Expiration Information
Lot# Lot: YK4W, Expiration date: 4/30/2029
Affected Packages Involved in this Recall
49401-102-01Product
49401-101-01Product
49401-088-42Product
49401-088-47Product
49401-088-50Product
49401-088-01Product
49401-088-35Product
49401-088-02Product
49401-088-61Product
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.
