CLASS III Drug recall · Reported 5 Mar 2014 · FDA Enforcement Report
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir recalled
Gilead Sciences is recalling Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), distributed nationwide in the US. The recall was initiated on 19 Feb 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-1090-2014
- FDA event ID
- 67557
- Recalling firm
- Gilead Sciences, Foster City, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Feb 2014
- FDA classified
- 27 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 19 Feb 2014 | Recall initiated by company | |
| 27 Feb 2014 | Classified by FDA | +8 days |
| 5 Mar 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: Red Silicone Rubber Particulates are Present in Drug.
Product as listed by the FDA
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
Where it was distributed
Nationwide including Puerto Rico.
Questions about this recall
Is Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) recalled?
Yes. Gilead Sciences recalled Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) on 19 Feb 2014. The recall is Class III and its status is Terminated. Recall number D-1090-2014.
Why was it recalled?
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Which lots are affected?
Lot #'s: 002390, 002400, Exp 02/17.
Where was it sold?
Nationwide including Puerto Rico.
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 21 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
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|---|---|---|---|---|---|
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |
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| Drug | CLASS II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL recalledEmtriva | Gilead Sciences | Packaging Defects | PR |
| Drug | CLASS III | Truvada (200 mg emtricitabine recalled by Gilead SciencesTruvada | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | AmBisome (amphotericin B) liposome for Injection, 50 mg recalled | Gilead Sciences | Sterility | CA |