CLASS I Drug recall · Reported 9 Oct 2024 · FDA Enforcement Report
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalled
Gilead Sciences is recalling Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 19 Sep 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0005-2025
- FDA event ID
- 95399
- Recalling firm
- Gilead Sciences, Foster City, CA
- Brand
- Veklury
- Manufacturer
- Gilead Sciences, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Sep 2024
- FDA classified
- 3 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Sep 2024 | Recall initiated by company | |
| 3 Oct 2024 | Classified by FDA | +14 days |
| 9 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Presence of glass particle.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the U.S.A.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Presence of glass particle.
Which lots are affected?
Lot: 47035CFA, Exp. 11/2025
Where was it sold?
Nationwide in the U.S.A.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Gilead Sciences
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL recalled | Gilead Sciences | Packaging Defects | PR |
| Drug | CLASS III | Truvada (200 mg emtricitabine recalled by Gilead SciencesTruvada | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS III | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir recalled | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | AmBisome (amphotericin B) liposome for Injection, 50 mg recalled | Gilead Sciences | Sterility | CA |
Other Remdesivir recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |