Medications & Supplements/Prescription Drugs

Xolair and RECOMBINATE Recalled for Temperature Storage Issues

Agency Publication Date: August 7, 2025

Summary

Cardinal Health Inc. is recalling 13 units of Xolair (omalizumab injection) and RECOMBINATE (Antihemophilic Factor [Recombinant]) because the products were exposed to temperatures outside of their labeled storage requirements. The recall includes 6 units of Xolair 150 mg/ml, 4 units of Xolair 75 mg/0.5 ml, and 3 units of RECOMBINATE 5 mL vials. These medications are used to treat asthma, chronic hives, and hemophilia, and their safety or effectiveness may be impacted by incorrect storage.

Risk

Exposure to temperatures outside of the required storage range can cause biological medications to degrade, potentially making the medication less effective or unsafe to use. No injuries or adverse events related to these specific units have been reported to date.

What You Should Do

This recall affects specific units of Xolair (omalizumab injection) 150 mg/ml and 75 mg/0.5 ml, and RECOMBINATE [Antihemophilic Factor (Recombinant)] 5 mL vials distributed nationwide by Cardinal Health Inc.
Identify if you have an affected product by checking the National Drug Code (NDC) and lot number on the packaging.
Check for Xolair 150 mg/ml with NDC 50242-215-55 and lot 3617756 (Exp 12/31/2025); Xolair 75 mg/0.5 ml with NDC 50242-214-55 and lot 3630004 (Exp 10/31/2025); or RECOMBINATE 5 mL with NDC 00944-2843-01 and lots TRB23802AC (Exp 03/18/2026) or TRA22804AA (Exp 10/18/2025).
If you have health concerns regarding these medications, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xolair (omalizumab injection) (150 mg/ml)

Variants: 1 auto-injector, Rx only

Lot Numbers:

3617756 (Exp 12/31/2025)

NDC:

50242-215-55

Distributed by Genentech, Inc.

Product: Xolair (omalizumab injection) (75 mg/0.5 ml)

Variants: Rx only

Lot Numbers:

3630004 (Exp 10/31/2025)

NDC:

50242-214-55

Distributed by Genentech, Inc.

Product: RECOMBINATE, [Antihemophilic Factor (Recombinant)] (5 mL vials)

Variants: Rx Only

Lot Numbers:

TRB23802AC (Exp 03/18/2026)

TRA22804AA (Exp 10/18/2025)

NDC:

00944-2843-01

Distributed by Takeda Pharmaceuticals USA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97360

Status: Active

Manufacturer: Cardinal Health Inc.

Sold By: Cardinal Health Inc.; Pharmacies

Manufactured In: United States

Units Affected: 3 products (6 units; 4 units; 3 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects specific units of Xolair (omalizumab injection) 150 mg/ml and 75 mg/0.5 ml, and RECOMBINATE [Antihemophilic Factor (Recombinant)] 5 mL vials distributed nationwide by Cardinal Health Inc.

Identify if you have an affected product by checking the National Drug Code (NDC) and lot number on the packaging.

Check for Xolair 150 mg/ml with NDC 50242-215-55 and lot 3617756 (Exp 12/31/2025); Xolair 75 mg/0.5 ml with NDC 50242-214-55 and lot 3630004 (Exp 10/31/2025); or RECOMBINATE 5 mL with NDC 00944-2843-01 and lots TRB23802AC (Exp 03/18/2026) or TRA22804AA (Exp 10/18/2025).

If you have health concerns regarding these medications, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health Inc. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xolair (omalizumab injection) (150 mg/ml)

Variants: 1 auto-injector, Rx only

Lot Numbers:

3617756 (Exp 12/31/2025)

NDC:

50242-215-55

Distributed by Genentech, Inc.

Product: Xolair (omalizumab injection) (75 mg/0.5 ml)

Variants: Rx only

Lot Numbers:

3630004 (Exp 10/31/2025)

NDC:

50242-214-55

Distributed by Genentech, Inc.

Product: RECOMBINATE, [Antihemophilic Factor (Recombinant)] (5 mL vials)

Variants: Rx Only

Lot Numbers:

TRB23802AC (Exp 03/18/2026)

TRA22804AA (Exp 10/18/2025)

NDC:

00944-2843-01

Distributed by Takeda Pharmaceuticals USA.