Micafungin for Injection Recalled for Incomplete Package Insert
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving labeling deficiency—specifically a missing or incomplete package insert. No illnesses, injuries, or deaths are reported. The hazard is informational and precautionary rather than direct product contamination or instability.
Plain-English summary
Xellia Pharmaceuticals USA, LLC is recalling Micafungin for Injection, 50 mg/vial, Single-Dose Vial (NDC 70594-036-01, Lot 467111, expiration 1/2023) nationwide. A total of 9,161 vials of 50 mg and 100 mg are affected.
The package insert provided with the product does not include all required sections approved for this product. Specifically, the insert is missing required information on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
Healthcare providers and patients should not use vials from the affected lot. Contact Xellia Pharmaceuticals USA, LLC for replacement product or further instructions.
The recalled product
- Product
- Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
- Manufacturer
- XELLIA PHARMACEUTICALS USA, LLC
- Category
- Drug — Injectable / Antifungal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 467111
- exp 1/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by XELLIA PHARMACEUTICALS USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · XELLIA PHARMACEUTICALS USA, LLC
See all →- ModerateMicafungin for Injection recalled for incomplete package insert
FDA (Drugs) · 2021-09-01
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