CLASS I Drug recall · Reported 24 Jul 2019 · FDA Enforcement Report
Fluorouracil Injection, USP (50 mg / mL) fill in a vial recalled
Fresenius Kabi USA is recalling Fluorouracil Injection, USP (50 mg / mL) fill in a vial, distributed nationwide in the US. The recall was initiated on 28 Jun 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1489-2019
- FDA event ID
- 83234
- Recalling firm
- Fresenius Kabi USA, Melrose Park, IL
- Brand
- Fluorouracil
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 Jun 2019
- FDA classified
- 17 Jul 2019
- Reported
- 24 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Jun 2019 | Recall initiated by company | |
| 17 Jul 2019 | Classified by FDA | +19 days |
| 24 Jul 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; glass particulates
Product as listed by the FDA
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; glass particulates
Which lots are affected?
Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Fluorouracil recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluorouracil 560 MG / IVP recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Fluorouracil 560 MG / IVP Fluorouracil 3340 MG QS 0.9% NACL recalled | Infusion Options | Sterility | NY |
| Drug | CLASS II | Fluorouracil 4250mg / D5W, Qty recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | Fluorouracil 4600mg / D5W, Qty recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | Fluorouracil 5760mg / D5W Qty recalled by Lincare | Lincare | Sterility | AR |