Quick answers
- What is Nirsevimab used for?
- The FDA-approved label (Beyfortus, Sanofi Vaccines US Inc., July 13, 2026) says: “BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nirsevimab have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nirsevimab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nirsevimab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nirsevimab?
- 1 company lists prescription products of Nirsevimab in the FDA NDC Directory, including Sanofi Vaccines US Inc..
What Nirsevimab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. …
— FDA label: Beyfortus, Sanofi Vaccines US Inc., effective July 13, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intramuscular |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Beyfortus |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sanofi Vaccines US Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761328 BEYFORTUS | Astrazeneca Ab | July 17, 2023 | 4, latest April 7, 2026 2026: Labeling · 2025: Efficacy · 2024: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2642406, 2642412, 2642414, 2642415 |
|---|---|
| SPL set ID of the quoted label | 2f08fa60-f674-432d-801b-1f9514bd9b39 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761328 |
| Active ingredients (FDA) | NIRSEVIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Beyfortus, Sanofi Vaccines US Inc., effective July 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →