Astellas Mycamine Injection Recall: Label Error on Declared Strength
Astellas recalls Mycamine (micafungin) injection vials due to labeling error on declared strength. Affected vials have specific NDC and expiration dates. No action needed for safety, but verify your product.
Lower-risk recall
Labeling: Label Error on Declared Strength
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What happened, in plain English
Astellas is recalling Mycamine (micafungin) injection vials because the label shows an incorrect declared strength. This error could lead to improper dosing if the product is used without checking the label. The recall does not pose an immediate safety risk to users. Read more at govinfonow.com/recall/40913-astellas-mycamine-injection-recall-label-error-on-declared-strength.
Source Summary by GovInfoNow · govinfonow.com/recall/40913-astellas-mycamine-injection-recall-label-error-on-declared-strength · Updated October 7, 2026 · FDA enforcement record: FDA #D-0548-2018
Cite this page
“Astellas Mycamine Injection Recall: Label Error on Declared Strength.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40913-astellas-mycamine-injection-recall-label-error-on-declared-strength. Based on FDA recall #D-0548-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0548-2018%22&limit=1).
Why it’s dangerous
The label error means the declared strength on the vial may not match the actual content. This could result in incorrect dosing if the product is used without verifying the label. However, the error does not cause immediate harm or injury.
Who’s affected
Patients prescribed Mycamine injections by a doctor who have the specific vial with NDC 0469-3211-10 and expiration dates listed. Healthcare providers using the product for medical treatment are most at risk.
How to tell if you have this one
Check for vials labeled 'Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only' with NDC 0469-3211-10 and expiration dates F1700164 (exp. 02/20) or A000000220 (exp. 06/20).
- Brand
Astellas- Category
Drug
What to do — step by step
Verify Product Label
Check the vial label for the NDC number 0469-3211-10 and expiration dates F1700164 (exp. 02/20) or A000000220 (exp. 06/20).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0548-2018 (January 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0548-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.