Multi-event July 2025 FDA Recall Xolair by Cardinal Health Inc.
This Multi-event Class II drug recall was voluntarily initiated by Cardinal Health Inc. on July 30, 2025 for the product Xolair. The FDA reported the reason for recall as cgmp deviations - product was exposed to temperatures outside the product's labeled storage requirements.. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0573-2025
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
07-30-2025
08-13-2025
3 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide Within the U.S.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Batch or Lot Expiration Information
Lot# Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Recall Number: D-0571-2025
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
07-30-2025
08-13-2025
6 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide Within the U.S.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Batch or Lot Expiration Information
Lot# Lot: 3617756, Expires: 12/31/2025.
Affected Packages Involved in this Recall
Recall Number: D-0572-2025
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
07-30-2025
08-13-2025
4 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide Within the U.S.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Batch or Lot Expiration Information
Lot# Lot: 3630004, Expires: 10/31/2025.
