Fresenius Kabi USA LLC
Fresenius Kabi USA LLC appears in FDA public data with 95 recalls — including 26 Class I (most serious) —, 2 510(k) clearances, 59 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0827-2026, Class I) was initiated on August 10, 2026. Its most recent 510(k) clearance was granted on December 4, 2018.
Summary
- Total Recalls
- 95 (26 Class I)
- 510(k) Clearances
- 2
- Inspections
- 59
- Compliance Actions
- 3
Known Names
fresenius kabi usa, fresenius kabi, usa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0827-2026 | Class I | Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by | August 10, 2026 |
| D-0788-2026 | Class I | Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramu | August 4, 2026 |
| D-0728-2026 | Class II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vial | July 16, 2026 |
| D-0726-2026 | Class II | Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per via | July 16, 2026 |
| D-0725-2026 | Class II | Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx o | July 16, 2026 |
| D-0727-2026 | Class II | Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-fiv | July 16, 2026 |
| D-0729-2026 | Class II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vial | July 16, 2026 |
| D-0581-2026 | Class III | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL | May 14, 2026 |
| Z-2224-2026 | Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | May 6, 2026 |
| Z-2223-2026 | Class I | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | May 6, 2026 |
| D-0424-2026 | Class II | 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL fre | March 11, 2026 |
| D-0425-2026 | Class II | 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius | March 11, 2026 |
| D-0433-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freef | March 11, 2026 |
| D-0430-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freefle | March 11, 2026 |
| D-0436-2026 | Class II | 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius | March 11, 2026 |
| D-0427-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex | March 11, 2026 |
| D-0431-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freefle | March 11, 2026 |
| D-0429-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Frankl | March 11, 2026 |
| D-0428-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex | March 11, 2026 |
| D-0435-2026 | Class II | 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius | March 11, 2026 |