Gilead Sciences, Inc.
NDC labeler codes: 55135, 61958
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Tenofovir disoproxil fumarateViread · 5 products
- SofosbuvirSovaldi · 4 products
- Emtricitabine and tenofovir disoproxil fumarateTruvada · 4 products
- Velpatasvir and sofosbuvirEpclusa · 4 products
- Ledipasvir and sofosbuvirHarvoni · 4 products
- Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBiktarvy · 3 products
- EmtricitabineEmtriva · 2 products
- Lenacapavir sodiumYeztugo, Sunlenca · 2 products
- AmbrisentanLetairis · 2 products
- IdelalisibZydelig · 2 products
- Emtricitabine and tenofovir alafenamideDescovy · 2 products
- RemdesivirVeklury · 1 product
- Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGenvoya · 1 product
- Tenofovir alafenamideVemlidy · 1 product
- Sofosbuvir, velpatasvir, and voxilaprevirVosevi · 1 product
- Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarateComplera · 1 product
- Elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateStribild · 1 product
- CobicistatTybost · 1 product
- Emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideOdefsey · 1 product
- BulevirtideHepcludex · 1 product
- Seladelpar lysineLivdelzi · 1 product
- Sacituzumab govitecanTrodelvy · 1 product
- Bictegravir/lenacapavirBixlenvo · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
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September 19, 2024 · Class I · Terminated · D-0005-2025 · Remdesivir
Presence of Particulate Matter: Presence of glass particle.
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
2021
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December 3, 2021 · Class I · Terminated · D-0299-2022 · Remdesivir
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
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
2014
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October 1, 2014 · Class II · Terminated · D-0045-2015 · Emtricitabine
Defective Container; leaking around the cap
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.
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September 30, 2014 · Class III · Terminated · D-0013-2015 · Emtricitabine and tenofovir disoproxil fumarate
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026