CLASS I Drug recall · Reported 5 Jan 2022 · 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 3 Dec 2021 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-0299-2022
- FDA event ID
- 89153
- Recalling firm
- Gilead Sciences, Foster City, CA
- Brand
- Veklury
- Manufacturer
- Gilead Sciences, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Dec 2021
- FDA classified
- 28 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Dec 2021 | Recall initiated by company | |
| 28 Dec 2021 | Classified by FDA | +25 days |
| 5 Jan 2022 | Published in enforcement report | +8 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: investigation into a customer complaint confirmed the presence of glass particulates.
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 USA
Questions about this recall
Is Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalled?
Yes. Gilead Sciences recalled Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial on 3 Dec 2021. The recall is Class I and its status is Terminated. Recall number D-0299-2022.
Why was it recalled?
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Which lots are affected?
Lots: 2141001-1A, 2141002-1A, Exp. 01/2024
Where was it sold?
Nationwide in the USA
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 21 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 recalledEmtriva | 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 |