Cardinal Health recalls Xolair 75mg injections due to temperature exposure during storage. This may affect product stability and safety for patients using this prescription medication.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health is recalling Xolair (omalizumab) injections that were exposed to temperatures outside their labeled storage requirements. This could potentially affect the product's stability and safety for patients using this prescription medication.
The product was exposed to temperatures outside the labeled storage requirements during manufacturing or distribution. This could potentially affect the product's stability and safety, though the exact risk level is not specified in the recall notice.
Patients with a prescription for Xolair 75mg/0.5ml injections who received this product from Cardinal Health. Those with specific medical conditions requiring this medication are most at risk.
Check for the product name Xolair (omalizumab injection), 75 mg/0.5 ml, prescription-only. The lot number 3630004 and expiration date 10/31/2025 are associated with this recall.
Verify the product name, lot number, and expiration date to confirm if it's part of this recall.
The recall states the product was exposed to temperatures outside labeled storage requirements, but does not specify if it's unsafe to use. Patients should check with their healthcare provider.
The recall record does not mention any replacement or remedy steps.
The recall record does not specify a remedy, so patients should check with their healthcare provider for guidance.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall D-0572-2025 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall D-0572-2025 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.
