Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Micafungin for Injection Recalled by XELLIA PHARMACEUTICALS USA, LLC Due to Labeling; Incorrect or Missing Package Insert: The package...
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 XELLIA PHARMACEUTICALS USA, LLC directly.
Affected Products
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
Quantity: 9,161 (50mg and 100 mg vials total)
Why Was This Recalled?
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About XELLIA PHARMACEUTICALS USA, LLC
XELLIA PHARMACEUTICALS USA, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report