Fresenius Kabi USA, LLC recalls Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC
Fresenius Kabi recalls 40mg/20mL ondansetron injection vials due to failed impurities and degradation specifications. This may pose a risk of harmful substances in the medication.
Recall notice
Failed Impurities/Degradation Specifications.
Contact the company & request your remedy
What happened, in plain English
Fresenius Kabi is recalling 40 mg/20 mL ondansetron injection vials that may contain impurities or degrade improperly. This could lead to harmful substances in the medication if used. Read more at govinfonow.com/recall/38772-fresenius-kabi-ondansetron-injection-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38772-fresenius-kabi-ondansetron-injection-recall-impurities-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1386-2019
Cite this page
“Fresenius Kabi Ondansetron Injection Recall: Impurities Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38772-fresenius-kabi-ondansetron-injection-recall-impurities-risk. Based on FDA recall #D-1386-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1386-2019%22&limit=1).
Why it’s dangerous
The recall is due to failed impurities and degradation specifications, meaning the medication may contain harmful substances or break down in a way that could be unsafe for patients. This could lead to adverse effects if the medication is used as intended.
Who’s affected
Patients prescribed ondansetron injections for nausea or vomiting, particularly those using the specific vial lot numbers mentioned in the recall. Healthcare providers administering the medication are also at risk.
How to tell if you have this one
Check for the vial label with 'Ondansetron Injection, USP, 40 mg / 20 mL' and the lot number 6018699, which expires December 2021. The product is sold by Fresenius Kabi USA, LLC.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number on the vial label to see if it matches 6018699.
Questions people ask
Is this product safe to use?
The recall indicates the product may contain impurities or degrade improperly, so it is not safe to use as intended.
What should I do if I have this product?
The official recall does not specify a remedy, so contact Fresenius Kabi USA, LLC for further instructions.
How can I confirm if I have the recalled product?
Check the vial label for the lot number 6018699 and expiration date of December 2021.
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-1386-2019 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-1386-2019 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-1386-2019 (May 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1386-2019 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.