Lower risk Drug recall · FDA · Published August 6, 2021

Xellia Micafungin Injection Recall: Missing Package Insert Risk

Xellia Pharmaceuticals recalls Micafungin 100mg vials due to missing critical package insert sections. This could affect patient safety information. Consumers should contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0757-2021Drug Xellia Pharmaceuticals ›

Lower-risk 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.

Take action

Contact the company

Recalling firmXELLIA PHARMACEUTICALS USA, LLC2150 E Lake Cook Rd · Buffalo Grove, IL 60089-1862

✎ GovInfoNow plain-language explainer

Xellia Pharmaceuticals is recalling Micaf:ungin for Injection vials because the package insert lacks required sections on adverse reactions, drug interactions, and specific populations. This could lead to safety risks if patients don't have complete instructions. Read more at govinfonow.com/recall/35987-xellia-micafungin-injection-recall-missing-package-insert-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35987-xellia-micafungin-injection-recall-missing-package-insert-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0757-2021

Cite this page

“Xellia Micafungin Injection Recall: Missing Package Insert Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35987-xellia-micafungin-injection-recall-missing-package-insert-risk. Based on FDA recall #D-0757-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0757-2021%22&limit=1).

The FDA announced on Aug. 6, 2021, that Xellia Pharmaceuticals USA LLC voluntarily recalled Micafungin for Injection due to labeling errors where the package insert lacked required sections. The agency classified this Class II recall as terminated.

How to tell if you have it

Brand: Xellia Pharmaceuticals
Product: Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only
NDC: 70594-037-01
Lot code: 467111
Expiration date: 1/2023
Quantity: 9,161 vials (50mg and 100 mg total)
Distribution: Nationwide USA

The hazard

According to the FDA, the package insert provided with the product does not include all required sections approved for this product. This omission includes aspects of Adverse Reactions, Drug Interactions, and Use in Specific Populations.

Context

GovInfoNow's records show other recent recalls of similar products include American Regent Levocarnitine Injection Recall (2026-04-16), Amneal Exenatide Injection Recall (2026-08-28), and Meitheal Cetrorelix Acetate Injection Kit Recall (2026-02-09).

How to tell if you have this one

Check for Micafungin for Injection 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, manufactured by Xellia Pharmaceuticals USA, LLC. Look for NDC 70594-037-01 and lot number 467111 (expires 1/2023).

Brand
Xellia Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide USA

Recall number	Product, codes & lots	Quantity
D-0756-2021	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; Lot 467111, exp 1/2023	9,161 vials 50 mg and 100 mg vials total
D-0757-2021	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; Lot 467111, exp 1/2023	9,161 (50mg and 100 mg vials total)

Based on the official FDA remedy

What to do — step by step

Check Package Insert
Verify the package insert includes all required sections for adverse reactions, drug interactions, and specific populations.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

Aug 6, 2021Firm started the recall
Aug 20, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report
Sep 29, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have the recalled product?

The recall does not require immediate action. Check the package insert for completeness and contact Xellia Pharmaceuticals for further guidance.

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Link to this recall

<a href="https://govinfonow.com/recall/35987-xellia-micafungin-injection-recall-missing-package-insert-risk">Xellia Micafungin Injection Recall: Missing Package Insert Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0757-2021 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0757-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.