CLASS III Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
Truvada (200 mg emtricitabine recalled by Gilead Sciences
Gilead Sciences is recalling Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, distributed nationwide in the US. The recall was initiated on 30 Sep 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0013-2015
- FDA event ID
- 69414
- Recalling firm
- Gilead Sciences, Foster City, CA
- Brand
- Truvada
- Manufacturer
- Gilead Sciences, Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Sep 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 30 Sep 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +9 days |
| 15 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Which lots are affected?
TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Gilead Sciences
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL recalledEmtriva | Gilead Sciences | Packaging Defects | PR |
| Drug | CLASS III | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir recalled | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | AmBisome (amphotericin B) liposome for Injection, 50 mg recalled | Gilead Sciences | Sterility | CA |
Other Emtricitabine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL recalledEmtriva | Gilead Sciences | Packaging Defects | PR |