Xolair Injection, Solution
FDA Recall NDC 50242-040
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Xolair (NDC 50242-040). A significant event, classified as Class II, was initiated on Jul 30, 2025 by Genentech, Inc.. The reported reason for this action was: "CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements."
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
July 2025 Class II Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall Number
Class II Ongoing
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Jul 30, 2025
Aug 13, 2025
6 units
Recall Profile & Regulatory Data
Event ID
97360
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide Within the U.S.
Product Description
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Batch or Lot Expiration Information
Lot# Lot: 3617756, Expires: 12/31/2025.
Affected Packages Involved in this Recall
50242-040-62Product
50242-040-86Product
50242-214-01Product
50242-214-86Product
50242-214-03Product
50242-214-55Product
50242-214-99Product
50242-214-83Product
50242-215-86Product
50242-215-01Product
50242-215-03Product
50242-215-55Product
50242-215-99Product
50242-215-83Product
50242-227-01Product
50242-227-55Product
50242-227-99Product
50242-227-86Product
July 2025 Class II Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall Number
Class II Ongoing
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Jul 30, 2025
Aug 13, 2025
4 units
Recall Profile & Regulatory Data
Event ID
97360
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide Within the U.S.
Product Description
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Batch or Lot Expiration Information
Lot# Lot: 3630004, Expires: 10/31/2025.
Affected Packages Involved in this Recall
50242-040-62Product
50242-040-86Product
50242-214-01Product
50242-214-86Product
50242-214-03Product
50242-214-55Product
50242-214-99Product
50242-214-83Product
50242-215-86Product
50242-215-01Product
50242-215-03Product
50242-215-55Product
50242-215-99Product
50242-215-83Product
50242-227-01Product
50242-227-55Product
50242-227-99Product
50242-227-86Product
Class II Terminated
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Jun 09, 2021
Jul 14, 2021
88,620 prefilled syringes
Recall Profile & Regulatory Data
Event ID
88100
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Genentech Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide
Termination Date
Aug 11, 2022
Product Description
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
Batch or Lot Expiration Information
Lot# Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
Affected Packages Involved in this Recall
50242-040-62Product
50242-040-86Product
50242-214-01Product
50242-214-86Product
50242-214-03Product
50242-214-55Product
50242-214-99Product
50242-214-83Product
50242-215-86Product
50242-215-01Product
50242-215-03Product
50242-215-55Product
50242-215-99Product
50242-215-83Product
50242-227-01Product
50242-227-55Product
50242-227-99Product
50242-227-86Product
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.
