Quick answers
- What is Xolair PFS?
- Xolair PFS is a brand name of Omalizumab, a prescription medicine. The FDA NDC Directory lists 2 Xolair PFS products in 2 strengths and forms.
- Who makes Xolair PFS?
- Genentech holds the FDA application for Xolair PFS (BLA103976, approved June 20, 2003).
- Is there a generic or store brand of Xolair PFS?
- Other products of Omalizumab are listed with the FDA, but none in exactly the same strength and form as a Xolair PFS product.
- Has Xolair PFS been recalled?
- FDA enforcement reports list 3 recalls of Xolair PFS products; the newest started July 30, 2025. A recall usually concerns specific lots, not every product.
What Xolair PFS is
Each Xolair PFS product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Omalizumab · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| omalizumab 150 mg/mL injection, solution (subcutaneous) | Xolair PFS | None listed | DailyMed |
| omalizumab 75 mg/0.5 mL injection, solution (subcutaneous) | Xolair PFS | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Omalizumab →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA103976 | Genentech | June 20, 2003 | 2 |
Companies that list Xolair PFS
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Xolair PFS products.
- Genentech, Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 30, 2025 · Class II · Ongoing · D-0571-2025
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55. — Cardinal Health Inc.
-
July 30, 2025 · Class II · Ongoing · D-0572-2025
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55 — Cardinal Health Inc.
-
June 9, 2021 · Class II · Terminated · D-0650-2021
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Fr — Genentech Inc
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.