Stop using now Drug recall · FDA · Published June 20, 2013

AmBisome Recall: Lack of Sterility Assurance in IV Vials

Gilead Sciences recalls AmBisome injection vials due to potential bacterial contamination from manufacturing simulation errors. Check lot numbers immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-821-2013Drug AmBisome ›

Stop using this now

Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.

Take action

Contact the company

Recalling firmGilead Sciences, Inc.333 Lakeside Drive · Foster City, CA 94404-1147

✎ GovInfoNow plain-language explainer

Gilead Sciences, Inc. is recalling AmBisome (amphotericin B) liposome for Injection, 50 mg, single-use vials distributed internationally. The recall stems from a routine manufacturing simulation that detected bacterial contamination in some media fill units, creating a possibility of contamination in the finished product. Although no contaminated batches have been identified in actual finished products, the risk remains. Read more at govinfonow.com/recall/47426-gilead-sciences-inc-recalls-ambisome-amphotericin-b-liposome-for-injection.

Source Summary by GovInfoNow · govinfonow.com/recall/47426-gilead-sciences-inc-recalls-ambisome-amphotericin-b-liposome-for-injection · Updated October 13, 2026 · FDA enforcement record: FDA #D-821-2013

Cite this page

“AmBisome Recall: Lack of Sterility Assurance in IV Vials.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47426-gilead-sciences-inc-recalls-ambisome-amphotericin-b-liposome-for-injection. Based on FDA recall #D-821-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-821-2013%22&limit=1).

Gilead Sciences, Inc. recalled AmBisome injection vials on June 20, 2013, due to a lack of sterility assurance, according to the FDA. The agency announced the Class II recall affecting 478,352 units distributed exclusively in foreign markets.

How to tell if you have it

Brand: AmBisome
Product: AmBisome (amphotericin B) liposome for Injection, 50 mg, Single-Use Vial
NDC: 0469-3051-30
Lot codes: 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2 (Exp 06/2015); 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD (Exp 07/2015 and 07/2016, Germany only); 042285AD (Exp 08/2015 and 8/2016, UK only); 042293AA, 042293AE, 042293AK, 042298AD (Exp 09/2015); 0422A6AD (Exp 10/15 for Finland, Greece, Turkey; Exp 10/2016 for Sweden, UK, Lebanon); 0422B0AD (Exp 10/2015 for Turkey, Netherlands, France; Exp 10/2016 for Poland); 0422B0AD1 (Exp 10/2015); 0422C1AA, 042304AD (Exp 01/2016 for Spain; Exp 01/2017 for Germany, Switzerland); 042304AD1, 042311AD (Exp 01/2016; Exp 01/2017 for France, UK)
Quantity: 478,352 vials
Distribution: Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark, Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden

The hazard

During a routine simulation of the manufacturing process, bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.

Context

GovInfoNow's records show Gilead Sciences, Inc. has had six other recalls on record since January 31, 2013. Other recent recalls of similar products include Accord IMULDOSA Injection Recall (June 10, 2026) and Reliance Pemetrexed Injection Recall (June 24, 2026).

How to tell if you have this one

Look for AmBisome (amphotericin B) liposome for Injection, 50 mg, single-use vials. Check the NDC 0469-3051-30 and specific lot numbers including 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, 042285AD, 042293AA, 042293AE, 042293AK, 042298AD, 0422A6AD, 0422B0AD, 0422B0AD1, 0422C1AA, and 042304AD, among others with expiration dates ranging from July 2015 to January 2017 depending on the region.

Brand
AmBisome
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your vials match the recalled lot numbers and expiration dates listed in the record.
Contact Healthcare Provider
If you have one of these vials, contact your healthcare provider or pharmacist immediately for guidance on disposal or replacement.

How this recall unfolded

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Jun 20, 2013Firm started the recall
Jul 25, 2013FDA classified it Class II
Jul 31, 2013Published in FDA’s Enforcement Report
Mar 5, 2014FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which countries received these recalled vials?

The vials were distributed only to foreign markets including France, Italy, Switzerland, Portugal, Denmark, Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, and Sweden.

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Link to this recall

<a href="https://govinfonow.com/recall/47426-gilead-sciences-inc-recalls-ambisome-amphotericin-b-liposome-for-injection">AmBisome Recall: Lack of Sterility Assurance in IV Vials (GovInfoNow)</a>

Where this comes from

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-821-2013 (June 20, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-821-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.