FDA Drug recall D-0013-2015
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Science…
- FDA Drug
- Class III
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class III recall of Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Science… by Gilead Sciences, citing presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0013-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-09-30 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Gilead Sciences |
| Distribution | US |
Product
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
Reason
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Identifiers
| ndc | 61958-0701-1 |
|---|---|
| ndc | 61958-0703-1 |
| ndc | 61958-0704-1 |
| ndc | 61958-0705-1 |
| code_info | TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2015%22
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