Food, drugs, devices › Gilead Sciences, Inc.
Drug recall: Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc.
Gilead Sciences, Inc. (Foster City, CA) initiated this drug recall on 31 Jan 2013; FDA lists 1 product record under event 64267, classified Class I.
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. 18% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 6 Jan 2014. 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: Particulate matter was found in some vials of Vistide (cidofovir injection)."
Distribution
"Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-324-2013 | Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1. | 3,181 vials | Class I | Terminated | 22 May 2013 |
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 |
| 3 Dec 2021 | 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 |
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: Particulate matter was found in some vials of Vistide (cidofovir injection)."
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 USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jan 2014. "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.