The Recall Desk
ModerateFDA (Drugs)·D-0572-2025·Announced 2025-08-13

Xolair 75 mg syringes exposed to temperatures outside labeled storage requirements

Xolair (omalizumab injection) 75 mg/0.5 mL is being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 4 units affected.

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 over a storage temperature excursion, with no confirmed potency or stability failure stated in the source.

Plain-English summary

Xolair (omalizumab injection), 75 mg/0.5 mL, prescription only, from Genentech, Inc. of South San Francisco, California, NDC 50242-214-55, is being recalled. The action covers 4 units.

The stated reason is CGMP deviations: the product was exposed to temperatures outside the product's labeled storage requirements. The FDA classified the action as Class II. The source does not report any confirmed loss of potency or stability.

The affected lot is 3630004, expiring 10/31/2025. Distribution was nationwide within the US.

Patients and facilities holding the affected lot should follow the instructions issued by Genentech.

The recalled product

Product
XOLAIR (OMALIZUMAB)
Brand
XOLAIR
Manufacturer
Cardinal Health Inc.
Category
Drug — Injectable biologic
Hazard
Affected units
4

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: 3630004
  • Expires: 10/31/2025.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · XOLAIR

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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