Xolair (omalizumab injection) recall
FDA recall D-0571-2025 · initiated Jul 30, 2025
Cardinal Health Inc. recalled Xolair (omalizumab injection) in Jul 2025 — an FDA Class II recall (D-0571-2025) because CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6 units
Details
- Product
- Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
- Recalling company
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide Within the U.S.
- Initiated
- Jul 30, 2025
- FDA report date
- Aug 13, 2025
This recall is linked to a product we cover: Xolair →
Frequently asked
- Was Xolair (omalizumab injection) recalled?
- Cardinal Health Inc. recalled Xolair (omalizumab injection) in Jul 2025 — an FDA Class II recall (D-0571-2025) because CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Xolair (omalizumab injection) recalled?
- Per the FDA enforcement record, the reason for recall D-0571-2025 was: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Is a recalled Xolair (omalizumab injection) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Xolair (omalizumab injection) are affected?
- Distributed: Nationwide Within the U.S.. The recall covers these lots — Lot: 3617756, Expires: 12/31/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0571-2025.