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 Sep 19, 2024. Its most recent FDA inspection ended on Feb 18, 2026 (Voluntary Action Indicated (VAI)).
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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 | Sep 19, 2024 |
| D-0299-2022 | Class I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead | Dec 3, 2021 |
| D-0045-2015 | Class II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sc | Oct 1, 2014 |
| D-0013-2015 | Class III | Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, R | Sep 30, 2014 |
| D-1090-2014 | Class III | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 T | Feb 19, 2014 |
| D-821-2013 | Class II | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use V | Jun 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 | Jan 31, 2013 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 18, 2026 | La Verne, CA | Drugs | Voluntary Action Indicated (VAI) | 3013189568 |
| Jan 16, 2026 | Foster City, CA | Drugs | No Action Indicated (NAI) | 1000523075 |
| Jan 29, 2025 | Foster City, CA | Drugs | No Action Indicated (NAI) | 1000523075 |
| Aug 22, 2024 | Oceanside, CA | Biologics | No Action Indicated (NAI) | 3012871330 |
| Jan 22, 2024 | Foster City, CA | Drugs | Voluntary Action Indicated (VAI) | 1000523075 |
| Dec 17, 2021 | La Verne, CA | Drugs | Voluntary Action Indicated (VAI) | 3013189568 |
| Aug 18, 2020 | Foster City, CA | Drugs | No Action Indicated (NAI) | 1000523075 |
| Jul 22, 2020 | Foster City, CA | Drugs | Voluntary Action Indicated (VAI) | 1000523075 |
| May 14, 2019 | La Verne, CA | Drugs | No Action Indicated (NAI) | 3013189568 |
| Apr 4, 2019 | Foster City, CA | Drugs | No Action Indicated (NAI) | 1000523075 |
| Jul 17, 2018 | Foster City, CA | Drugs | Voluntary Action Indicated (VAI) | 1000523075 |
| Apr 26, 2018 | San Dimas, CA | Drugs | No Action Indicated (NAI) | 2082946 |
| May 11, 2016 | Foster City, CA | Drugs | Voluntary Action Indicated (VAI) | 1000523075 |
| Apr 14, 2016 | Foster City, CA | Drugs | No Action Indicated (NAI) | 1000523075 |
| Jan 19, 2016 | San Dimas, CA | Drugs | No Action Indicated (NAI) | 2082946 |
| Jul 25, 2014 | Foster City, CA | Drugs | Voluntary Action Indicated (VAI) | 1000523075 |
| May 16, 2014 | San Dimas, CA | Drugs | Voluntary Action Indicated (VAI) | 2082946 |
| Mar 6, 2014 | Seattle, WA | Drugs | Voluntary Action Indicated (VAI) | 3008329365 |
| Jan 15, 2014 | Foster City, CA | Drugs | No Action Indicated (NAI) | 1000523075 |
| Oct 9, 2013 | Foster City, CA | Drugs | Voluntary Action Indicated (VAI) | 1000523075 |