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 Astellas Pharma US Inc Due to Lack of Assurance of Sterility; Astellas Pharma US,...
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 Astellas Pharma US Inc directly.
Affected Products
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, 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: 133,550 Vials
Why Was This Recalled?
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Astellas Pharma US Inc
Astellas Pharma US Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report