Micafungin for Injection — Class II drug recall D-0757-2021
Terminated recall by XELLIA PHARMACEUTICALS USA, LLC, reported 2021-09-01, distributed nationwide. Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include a
| Recall number | D-0757-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | XELLIA PHARMACEUTICALS USA, LLC, Buffalo Grove, IL, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-08-20 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2024-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 9,161 |
| Reason classes | labeling |
| NDC | 70594-0037-01 |
| Lot numbers | 467111 |
| Expiration dates | 2023-01 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0757-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.