Genentech Xolair 150mg Injection Recall: Stability Issues
Genentech recalls Xolair 150mg prefilled syringes due to stability problems detected at 12 months. Affected lots expired August 2021. No remedy specified in official notice.
Recall notice
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Contact the company
What happened, in plain English
Genentech is recalling Xolair 150mg prefilled syringes that failed stability tests after 12 months. This means the medication may not be safe for use once the expiration date passes. Affected products were manufactured in August 2021 and should be checked for the specific lot numbers. Read more at govinfonow.com/recall/36119-genentech-xolair-150mg-injection-recall-stability-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/36119-genentech-xolair-150mg-injection-recall-stability-issues · Updated August 18, 2026 · FDA enforcement record: FDA #D-0650-2021
Cite this page
“Genentech Xolair 150mg Injection Recall: Stability Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36119-genentech-xolair-150mg-injection-recall-stability-issues. Based on FDA recall #D-0650-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2021%22&limit=1).
Why it’s dangerous
The medication failed stability tests at the 12-month mark, indicating potential degradation of the active ingredient. This could lead to ineffective treatment or adverse reactions if used beyond the expiration date.
Who’s affected
People with prescriptions for Xolair 150mg injections who received the recalled lots (3352758 or 3352759) from August 2021. Those using the product after the expiration date may be at risk.
How to tell if you have this one
Check the product label for the lot number 3352758 or 3352759 with expiration date August 2021. The product is a single-dose prefilled syringe for subcutaneous use.
- Brand
Genentech- Category
Drug
What to do — step by step
Check Product Label
Look for lot numbers 3352758 or 3352759 with expiration date August 2021 on the syringe.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0650-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0650-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.