Cardinal Health recalls Xolair (omalizumab injection) due to temperature exposure during storage. This may affect product stability and safety. Check your NDC number for affected lots.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health is recalling Xolair (omalizumab injection) because it was exposed to temperatures outside its labeled storage requirements. This could potentially affect the product's stability and safety, though the recall does not specify immediate harm to users.
The product was exposed to temperatures outside its labeled storage requirements during manufacturing. This could lead to instability in the medication, potentially affecting its effectiveness or safety, though the recall does not indicate immediate harm to users.
People with prescriptions for Xolair (omalizumab injection) who have the specific lot number 3617756. Those using the product for allergies treatment are most at risk if the product was stored improperly.
Check the NDC number 50242-215-55 on the product label. The affected lot number is 3617756, and the expiration date is 12/31/2025.
Look for the NDC number 50242-215-55 and lot number 3617756 on the Xolair auto-injector.
The recall states the product was exposed to improper temperatures during storage, but does not indicate immediate harm to users if used correctly.
The recall does not specify a remedy, so no action is required beyond checking the product label for the affected lot number.
Check the NDC number 50242-215-55 and lot number 3617756 on the product label.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall D-0571-2025 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall D-0571-2025 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
