Fresenius Kabi USA, LLC recalls Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;
Fresenius Kabi recalls Fosaprepitant injection vials with incorrect EDTA labeling. This labeling error may affect medication accuracy. Affected vials have specific NDC and lot numbers. Contact for details.
Lower-risk recall
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Contact the company & request your remedy
What happened, in plain English
Fresenius Kabi is recalling certain Fosaprepitant injection vials due to a labeling error that incorrectly states the amount of EDTA. This error could lead to inaccurate medication dosing if the vial is used without correction. Read more at govinfonow.com/recall/36935-fresenius-kabi-fosaprepitant-injection-recall-labeling-error-in-edta-quantity.
Source Summary by GovInfoNow · govinfonow.com/recall/36935-fresenius-kabi-fosaprepitant-injection-recall-labeling-error-in-edta-quantity · Updated October 5, 2026 · FDA enforcement record: FDA #D-1391-2020
Cite this page
“Fresenius Kabi Fosaprepitant Injection Recall: Labeling Error in EDTA Quantity.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36935-fresenius-kabi-fosaprepitant-injection-recall-labeling-error-in-edta-quantity. Based on FDA recall #D-1391-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1391-2020%22&limit=1).
Why it’s dangerous
The label incorrectly states the EDTA content as 5.4 mg per vial instead of the actual 18.8 mg. This discrepancy could lead to inaccurate medication dosing if the vial is used without correction, potentially affecting treatment efficacy.
Who’s affected
Healthcare professionals who use Fosaprepitant injections for cancer treatment. Patients receiving this medication under medical supervision are most at risk if the labeling error affects dosing accuracy.
How to tell if you have this one
Check for vials with NDC 63323-972-10, lot numbers 6122760, 6122761 (exp 08/2021), 6122762 (exp 09/2021), or 6123883 (exp 03/2022). These vials are labeled with incorrect EDTA quantities.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Vial Label
Verify the EDTA quantity on the label; if it shows 5.4 mg instead of 18.8 mg, this vial is affected.
Questions people ask
Why is this labeling error a problem?
The label incorrectly states the EDTA content as 5.4 mg per vial instead of the actual 18.8 mg. This could lead to inaccurate medication dosing if the vial is used without correction.
What should I do if I have this vial?
The recall does not specify a remedy, so contact Fresenius Kabi for guidance on handling affected vials.
Are there specific lot numbers affected?
Yes, affected vials have lot numbers 6122760, 6122761 (exp 08/2021), 6122762 (exp 09/2021), or 6123883 (exp 03/2022).
Contact Fresenius Kabi
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-1391-2020 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-1391-2020 from Fresenius Kabi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1391-2020 (July 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1391-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.