Truvada — Class III drug recall D-0013-2015
Terminated recall by Gilead Sciences, Inc., reported 2014-10-15, distributed nationwide. Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
| Recall number | D-0013-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gilead Sciences, Inc., Foster City, CA, United States |
| Recall initiated | 2014-09-30 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 10,317 bottles |
| Reason classes | specification failure |
| NDC | 61958-0701, 61958-0701-01, 61958-0703, 61958-0703-01, 61958-0704, 61958-0704-01, 61958-0705, 61958-0705-01 |
| Lot numbers | 002808 |
| Expiration dates | 2017-12-31 |
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 for recall
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0013-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.