Medications & Supplements/Prescription Drugs

Genentech Inc: Xolair Injection Recalled for Failing Stability Standards

Agency Publication Date: July 6, 2021

Summary

Genentech Inc. has issued a voluntary recall for approximately 88,620 units of Xolair (omalizumab) Injection (150 mg/1 mL). This prescription medication, used for subcutaneous injection, is being recalled because routine testing at the 12-month mark showed that the Polysorbate 20 (PS20) content was outside of the required safety and quality specifications. If you use this medication, you should contact your healthcare provider or pharmacist for guidance on how to handle the affected product and obtain a replacement.

Risk

The stability of the medication has failed due to incorrect levels of Polysorbate 20, which is an inactive ingredient used to stabilize the drug. This failure to meet specifications could potentially impact the effectiveness or safety of the medication over time.

What You Should Do

Check your Xolair (omalizumab) packaging for NDC number 50242-215-01 to see if your product is part of this recall.
Locate the lot number and expiration date on the side of the prefilled syringe carton. The affected products are Lot No. 3352758 with an expiration date of August 2021, and Lot No. 3352759 with an expiration date of August 2021.
If your medication matches the affected lot numbers, contact your healthcare provider or pharmacist immediately for medical guidance and instructions on how to receive a replacement.
Return any unused prefilled syringes from these specific lots to your pharmacy to receive a refund.
Contact Genentech Inc. directly for further instructions regarding the return process or if you have questions about the affected batches.
For additional information or questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug recall guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Xolair (omalizumab) Injection (150 mg/1 mL)

Model:

NDC: 50242-215-01

Recall #: D-0650-2021

Lot Numbers:

3352758 (Exp. Aug 2021)

3352759 (Exp. Aug 2021)

Date Ranges: August 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88100

Status: Resolved

Manufacturer: Genentech Inc

Sold By: Pharmacies; Healthcare Providers

Manufactured In: France, United States

Units Affected: 88,620 prefilled syringes

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

Check your Xolair (omalizumab) packaging for NDC number 50242-215-01 to see if your product is part of this recall.

Locate the lot number and expiration date on the side of the prefilled syringe carton. The affected products are Lot No. 3352758 with an expiration date of August 2021, and Lot No. 3352759 with an expiration date of August 2021.

If your medication matches the affected lot numbers, contact your healthcare provider or pharmacist immediately for medical guidance and instructions on how to receive a replacement.

Return any unused prefilled syringes from these specific lots to your pharmacy to receive a refund.

Contact Genentech Inc. directly for further instructions regarding the return process or if you have questions about the affected batches.

For additional information or questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).