Gilead Sciences, Inc.
Gilead Sciences, Inc. appears in FDA public data with 7 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 29 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0005-2025, Class I) was initiated on September 19, 2024.
Summary
- Total Recalls
- 7 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 29
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0005-2025 | Class I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead | September 19, 2024 |
| D-0299-2022 | Class I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead | December 3, 2021 |
| D-0045-2015 | Class II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sc | October 1, 2014 |
| D-0013-2015 | Class III | Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, R | September 30, 2014 |
| D-1090-2014 | Class III | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 T | February 19, 2014 |
| D-821-2013 | Class II | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use V | June 20, 2013 |
| D-324-2013 | Class I | Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: G | January 31, 2013 |