CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report
5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalled
Fresenius Kabi USA is recalling 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex, Fresenius Kabi USA, LLC, distributed nationwide in the US. The recall was initiated on 11 Mar 2026 and the FDA has classified it as Class II.
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-0436-2026
- FDA event ID
- 98581
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Dextrose
- Manufacturer
- FRESENIUS KABI USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2026
- FDA classified
- 3 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Mar 2026 | Recall initiated by company | |
| 3 Apr 2026 | Classified by FDA | +23 days |
| 15 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
Where it was distributed
US Nationwide , Alaska, and Puerto Rico.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
Where was it sold?
US Nationwide , Alaska, 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
13 other products · FDA event 98581This product is part of a recall event; the main page for the event is 0.9% Sodium Chloride Injection, USP, (2,250 mg recalled.
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 Dextrose recalls
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Dextrose Injection recalled by B Braun MedicalDextrose | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | Delflex Peritoneal Dialysis Solution With Low Magnesium recalledDelflex | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |