Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Abelcet (Amphotericin B Lipid Complex) Injection Recalled by Leadiant Biosciences, Inc. Due to Lack of assurance of sterility: Medial fill with...

Date: February 3, 2023
Company: Leadiant Biosciences, Inc.
Status: Terminated
Source: FDA (Drug)

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 Leadiant Biosciences, Inc. directly.

Affected Products

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41

Quantity: 31,879 vials

Why Was This Recalled?

Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Leadiant Biosciences, Inc.

Leadiant Biosciences, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report