Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97360

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 30, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cardinal Health Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

D-0571-2025
Recall number
D-0571-2025
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health Inc.
Quantity
6 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Code information

Lot: 3617756, Expires: 12/31/2025.

Distribution pattern

Nationwide Within the U.S.

drug · product 2 of 3

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

D-0572-2025
Recall number
D-0572-2025
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health Inc.
Quantity
4 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Code information

Lot: 3630004, Expires: 10/31/2025.

Distribution pattern

Nationwide Within the U.S.

drug · product 3 of 3

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

D-0573-2025
Recall number
D-0573-2025
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health Inc.
Quantity
3 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Code information

Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025

Distribution pattern

Nationwide Within the U.S.