Food, drugs, devices › Gilead Sciences, Inc.
Drug recall: Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos
FDA enforcement event 89153 is a drug recall by Gilead Sciences, Inc. of Foster City, CA, initiated 3 Dec 2021 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 19% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 25 Jul 2022. Initiation: voluntary: firm initiated. Gilead Sciences, Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gilead Sciences, Inc., Foster City, CA.
Reason for recall
"Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0299-2022 | 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 | 53,473 vials | Class I | Terminated | 5 Jan 2022 |
Context
Other enforcement events for Gilead Sciences, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Sep 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos | Drug | Class I | 1 |
| 1 Oct 2014 | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster | Drug | Class II | 1 |
| 30 Sep 2014 | Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured | Drug | Class III | 1 |
| 19 Feb 2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx on | Drug | Class III | 1 |
| 20 Jun 2013 | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Market | Drug | Class II | 1 |
| 31 Jan 2013 | Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc. | Drug | Class I | 1 |
All 7 events for Gilead Sciences, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Jul 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.