company
Fresenius Kabi USA, LLC
Jurisdiction: US
FDA Warning Letter timeline
V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.
- fda_recall · device_recall2026-06-17Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby Dialysate; Model number: RFP-400-G;
- fda_recall · device_recall2026-06-17Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G,…
- fda_recall · drug_recall2026-06-17Fresenius Kabi USA, LLC — Class III recall: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka…
- fda_recall · device_recall2026-06-10Fresenius Kabi USA, LLC — Class II recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: L…
- fda_recall · device_recall2026-06-10Fresenius Kabi USA, LLC — Class I recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- fda_recall · device_recall2026-06-10Fresenius Kabi USA, LLC — Class I recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- fda_recall · drug_recall2026-05-13Fresenius Medical Care Holdings, Inc. — Class II recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange…
- fda_recall · drug_recall2026-05-13Fresenius Medical Care Holdings, Inc. — Class II recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL free…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 B…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 25…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL f…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL,…
- fda_recall · drug_recall2026-04-15Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a…
Frequently asked questions
- How many FDA warning letters has Fresenius Kabi USA, LLC received?
- Argus HQ has not recorded an FDA warning letter for Fresenius Kabi USA, LLC in our current dataset.
- What FDA recalls has Fresenius Kabi USA, LLC issued?
- Argus HQ has recorded 22 FDA recalls tied to Fresenius Kabi USA, LLC.
- Is Fresenius Kabi USA, LLC FDA compliant?
- Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 22 recalls, and 0 approval records for Fresenius Kabi USA, LLC. Review the linked FDA source records directly before drawing a compliance conclusion.
Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.