Truvada Recall: Foreign Silicone Particulates Found
Gilead Sciences recalls Truvada tablets due to small red silicone rubber particulates. Check your lot number and expiration date for affected bottles.
Use caution until it’s fixed
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Contact the company
What happened, in plain English
Gilead Sciences, Inc. is recalling specific lots of Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets because they were found to contain small red silicone rubber particulates. The recall affects 10,317 bottles distributed nationwide. This is a Class III recall. Read more at govinfonow.com/recall/45747-gilead-sciences-inc-recalls-truvada-200-mg-emtricitabine-and-300.
Source Summary by GovInfoNow · govinfonow.com/recall/45747-gilead-sciences-inc-recalls-truvada-200-mg-emtricitabine-and-300 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0013-2015
Cite this page
“Truvada Recall: Foreign Silicone Particulates Found.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45747-gilead-sciences-inc-recalls-truvada-200-mg-emtricitabine-and-300. Based on FDA recall #D-0013-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2015%22&limit=1).
Why it’s dangerous
The tablets contain small red silicone rubber particulates, which is a foreign substance not intended to be in the medication. The record does not describe specific health consequences or injury mechanisms resulting from ingesting these particulates.
Who’s affected
Patients who have been prescribed Truvada and possess bottles from the specific lot number listed in the record are affected. While the hazard involves foreign material, the record does not specify immediate injury risks or provide a remedy for patients to follow.
How to tell if you have this one
Check your bottle for the NDC 61958-0701-1 and Lot# 002808 with an expiration date of 31 December 2017. The product is a 30 count bottle of Truvada tablets manufactured for Gilead Sciences, Inc.
- Brand
Truvada- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0013-2015 (September 30, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0013-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.