Fresenius Kabi USA, LLC recalls Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,
Fresenius Kabi recalls Fluorouracil Injection vials with glass particulates that could cause serious injury during medical use. Affected lots include NDC 63323-117-61 and 63323-117-69.
Use caution until it’s fixed
Presence of Particulate Matter; glass particulates
Contact the company & request your remedy
What happened, in plain English
Fresenius Kabi is recalling Fluorouracil Injection vials that may contain glass particles. This hazard could cause serious injury if the medication is administered improperly. Read more at govinfonow.com/recall/38488-fresenius-kabi-fluorouracil-injection-recall-glass-particulates-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38488-fresenius-kabi-fluorouracil-injection-recall-glass-particulates-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1489-2019
Cite this page
“Fresenius Kabi Fluorouracil Injection Recall: Glass Particulates Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38488-fresenius-kabi-fluorouracil-injection-recall-glass-particulates-risk. Based on FDA recall #D-1489-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1489-2019%22&limit=1).
Why it’s dangerous
Glass particles in the injection vials could become dislodged during administration, potentially causing tissue damage or serious injury to the patient. This risk is particularly concerning for chemotherapy treatments where precise delivery is critical.
Who’s affected
Patients receiving chemotherapy treatment with this specific Fluorouracil injection are affected. Healthcare providers using the product in clinical settings are at risk.
How to tell if you have this one
Check for vials labeled with NDC 63323-117-61 (Fresenius Kabi brand) or NDC 63323-117-69 (NOVAPLUS brand). The affected lots are 6120420 and 6120341.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Vial Label
Look for the NDC codes 63323-117-61 or 63323-117-69 on the vial label.
Contact Healthcare Provider
If you have the affected vial, inform your healthcare provider immediately about the product lot number.
Questions people ask
Is this product safe to use?
The product may contain glass particles that could cause serious injury during administration. Do not use the affected vials.
What should I do if I have the affected vial?
Contact your healthcare provider immediately and do not use the vial. They will advise on next steps.
How can I identify the affected lots?
Check the vial label for NDC 63323-117-61 (Fresenius Kabi brand) or NDC 63323-117-69 (NOVAPLUS brand) with lot numbers 6120420 or 6120341.
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-1489-2019 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-1489-2019 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-1489-2019 (June 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1489-2019 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.