Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AmBisome (amphotericin B) liposome for Injection Recalled by Gilead Sciences, Inc. Due to Lack of Sterility Assurance; During a routine simulation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Gilead Sciences, Inc. directly.
Affected Products
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
Quantity: 478,352 vials
Why Was This Recalled?
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.
Where Was This Sold?
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, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report