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

FDA Recalls Xolair Injectable for Temperature Storage Deviation

The FDA is recalling Xolair (omalizumab) 75 mg subcutaneous injection due to exposure to temperatures outside labeled storage requirements during distribution. No adverse events have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification indicates potential for serious adverse effects from manufacturing deviation. Although no illnesses or injuries have been reported, the temperature exposure of a stored prescription medication could affect stability and safety.

Plain-English summary

The FDA is recalling Xolair (omalizumab) 75 mg subcutaneous injection manufactured by Genentech Inc. and distributed by Cardinal Health Inc. This is a Class II recall due to a Current Good Manufacturing Practice (CGMP) deviation.

The product was exposed to temperatures outside the labeled storage requirements during distribution. The affected product is Lot 3630004, which expires October 31, 2025, and was distributed nationwide within the United States.

No illnesses or injuries related to this product have been reported. Consumers with this lot should consult with their healthcare provider or pharmacist about whether to continue use or obtain a replacement.

The recalled product

Product
XOLAIR (OMALIZUMAB)
Brand
XOLAIR
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Injectable
Hazard
  • storage-temperature-excursion
  • cgmp-deviation

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.

Related recalls

Same brand · XOLAIR

Same category