📍Recalling firmGilead Sciences, Inc.333 Lakeside Dr · Foster City, CA 94404-1147
✎ GovInfoNow plain-language explainer
Gilead Sciences, Inc. is recalling specific lots of Emtriva (emtricitabine) Oral Solution because the containers are defective and may leak around the cap. The recall affects 6,290 bottles distributed in the United States, Puerto Rico, and Fiji. The company has not yet provided a remedy or instructions for consumers. Read more at govinfonow.com/recall/45745-gilead-sciences-inc-recalls-emtriva-emtricitabine-oral-solution-10-mg.
“Gilead Recalls Emtriva Oral Solution Due to Leaking Caps.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45745-gilead-sciences-inc-recalls-emtriva-emtricitabine-oral-solution-10-mg. Based on FDA recall #D-0045-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0045-2015%22&limit=1).
The FDA announced on Oct. 1, 2014, that Gilead Sciences is recalling Emtriva Oral Solution due to defective containers leaking around the cap. The voluntary Class II recall affects 6,290 bottles distributed in the United States, Puerto Rico, and Fiji.
How to tell if you have it
Brand: Gilead Sciences
Product: Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles
Expiration dates: June 30, 2015; Oct. 31, 2015; April 30, 2016; Oct. 31, 2016
The hazard
According to the FDA, the hazard is a defective container causing leakage around the cap of the Emtriva Oral Solution bottles.
Context
GovInfoNow's records show Gilead Sciences has had six other recalls since Jan. 31, 2013, including Veklury injection recalls on Sept. 19, 2024, and Dec. 3, 2021, for glass particulates. Other recent recalls of similar products include Keystone Dental City Topical Anesthetic Gel (May 21, 2026), Keystone Burkhart Anesthetic Gel (May 21, 2026), and Keystone DHP Topical Anesthetic Gel (May 21, 2026) for defective container risks.
How to tell if you have this one
Check your bottle for the following details: Product is Emtriva (emtricitabine) Oral Solution, 10 mg/mL in 170 mL bottles. Look for NDC 61958-0602-1 and one of these FG Lot Numbers with their expiration dates: HDNTD1 (exp 30-Jun-15), KCMGD or KCMGD1 (exp 31-Oct-15), KYGHA, KYGKA, or KYGKK (exp 30-Apr-16), or MZVBA or MZTZA (exp 31-Oct-16).
Brand
Gilead Sciences
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Lot Number
Compare the lot number and expiration date on your bottle against the specific lots listed in the recall record.
Contact Your Pharmacist
If you have a recalled bottle, contact your pharmacy or healthcare provider to discuss next steps since no official remedy is currently stated.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “United States, Puerto Rico, Fiji.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0045-2015 (October 1, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0045-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.