Prescription injectable medication recalled due to improper storage temperature exposure
XOLAIR (omalizumab) injectable is being recalled due to exposure to temperatures outside its labeled storage requirements. The affected lot (3617756) was distributed nationwide. Patients should contact their healthcare provider regarding their supply.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—potential loss of medication efficacy due to temperature exposure—is based on manufacturing process deviation, not confirmed product failure. Per the severity rubric, absence of reported harm keeps this at Moderate level.
Plain-English summary
XOLAIR (omalizumab) 150 mg/ml auto-injector, Lot 3617756, is being recalled due to a Current Good Manufacturing Practice (CGMP) deviation. Cardinal Health Inc. initiated the recall because the product was exposed to temperatures outside the manufacturer's labeled storage requirements.
Temperature exposure may compromise the product's integrity and effectiveness. This is a prescription medication, and loss of potency could prevent it from working as intended.
Patients who have received units from Lot 3617756 should contact their healthcare provider immediately. Healthcare providers should verify patient records against the affected lot number and discuss appropriate next steps with patients, which may include product replacement or continued monitoring.
The recalled product
- Product
- XOLAIR (OMALIZUMAB)
- Brand
- XOLAIR
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug
- Hazard
- improper-storage
- potency-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 3617756
- Expires: 12/31/2025.
Distribution
Distributed nationwide across the United States.
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