Quick answers
- What is Remdesivir used for?
- The FDA-approved label (Veklury, Gilead Sciences, Inc., July 29, 2026) says: “VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are […]: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Remdesivir 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 Remdesivir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Remdesivir been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started September 19, 2024 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Remdesivir?
- 1 company lists prescription products of Remdesivir in the FDA NDC Directory, including Gilead Sciences, Inc..
What Remdesivir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are […]: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. …
— FDA label: Veklury, Gilead Sciences, Inc., effective July 29, 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, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Veklury |
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.
- Gilead Sciences, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA214787 VEKLURY | Gilead Sciences Inc | October 22, 2020 | 23, latest July 29, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 19, 2024 · Class I · Terminated · D-0005-2025
Presence of Particulate Matter: Presence of glass particle.
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2 — Gilead Sciences, Inc.
-
December 3, 2021 · Class I · Terminated · D-0299-2022
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2 — Gilead Sciences, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 2284960, 2367758, 2395502, 2395504 |
|---|---|
| SPL set ID of the quoted label | c0978fa8-53ff-4ca2-82a7-567fd3e958ca |
| FDA labels (SPL) | 1 |
| FDA applications | NDA214787 |
| Active ingredients (FDA) | REMDESIVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Veklury, Gilead Sciences, Inc., effective July 29, 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 →