Fresenius Kabi USA, LLC recalls Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per
Fresenius Kabi recalls 24-pack midazolam injection syringes that are mislabeled with ondansetron instead. This mix-up could lead to incorrect medication use. Consumers should check their syringes and contact the company for details.
Use caution until it’s fixed
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Contact the company & request your remedy
What happened, in plain English
Fresenius Kabi is recalling 24-pack midazolam injection syringes that are mislabeled as containing ondansetron instead. This mix-up could cause patients to receive the wrong medication, which may lead to serious health risks. Read more at govinfonow.com/recall/41117-fresenius-kabi-midazolam-syringes-recalled-due-to-label-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/41117-fresenius-kabi-midazolam-syringes-recalled-due-to-label-mix-up · Updated October 7, 2026 · FDA enforcement record: FDA #D-0152-2018
Cite this page
“Fresenius Kabi Midazolam Syringes Recalled Due to Label Mix-Up.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41117-fresenius-kabi-midazolam-syringes-recalled-due-to-label-mix-up. Based on FDA recall #D-0152-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0152-2018%22&limit=1).
Why it’s dangerous
The syringes are labeled as midazolam injection but contain ondansetron instead. This mix-up could lead to patients receiving the incorrect medication, which might cause serious health issues.
Who’s affected
Patients using midazolam injection syringes for medical purposes are affected. Those with the mislabeled syringes are at risk of receiving the wrong medication.
How to tell if you have this one
Check for blister packs labeled as 'Midazolam injection, USP, 2 mg / 2 ml' that contain syringes of ondansetron. The product was sold with NDC 76045-001-20 and lot number 6400048.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Syringe Label
Look for blister packs labeled as Midazolam injection, USP, 2 mg / 2 ml that contain ondansetron syringes instead.
Questions people ask
What is the product being recalled?
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton.
How can I tell if I have the recalled product?
Check for blister packs labeled as Midazolam injection, USP, 2 mg / 2 ml that contain syringes of ondansetron instead. The product was sold with NDC 76045-001-20 and lot number 6400048.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Fresenius Kabi USA, LLC for further instructions.
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-0152-2018 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-0152-2018 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-0152-2018 (October 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0152-2018 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.