CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Emtriva (emtricitabine) Oral Solution, 10 mg/mL recalled
Gilead Sciences is recalling Emtriva (emtricitabine) Oral Solution, 10 mg/mL, distributed in Puerto Rico. The recall was initiated on 1 Oct 2014 and the FDA has classified it as Class II.
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-0045-2015
- FDA event ID
- 69411
- Recalling firm
- Gilead Sciences, Foster City, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2014
- FDA classified
- 24 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 1 Oct 2014 | Recall initiated by company | |
| 24 Oct 2014 | Classified by FDA | +23 days |
| 5 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container; leaking around the cap
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.
Where it was distributed
United States, Puerto Rico, Fiji.
Questions about this recall
Why was it recalled?
Defective Container; leaking around the cap
Which lots are affected?
FG Lot Number: HDNTD1 and HDNTD exp 30-Jun-15, KCMGD and KCMGD1 exp 31-Oct-15, KYGHA, KYGKA and KYGKK exp 30-Apr-16, MZVBA and MZTZA exp 31-Oct-16
Where was it sold?
United States, Puerto Rico, Fiji.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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