Atripla — Class III drug recall D-1090-2014
Terminated recall by Gilead Sciences, Inc., reported 2014-03-05, distributed nationwide. Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
| Recall number | D-1090-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gilead Sciences, Inc., Foster City, CA, United States |
| Recall initiated | 2014-02-19 |
| Classified | 2014-02-27 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 39,223 bottles |
| Reason classes | specification failure |
| NDC | 15584-0101-01 |
| Lot numbers | 002390, 002400, 02/17 |
Product
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland
Reason for recall
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
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-1090-2014. 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.