Fresenius Kabi USA, LLC — FDA Enforcement History

FDA action counts

Enforcement history

On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius 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… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius 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,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius 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… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius 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… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius 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… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Fresenius Kabi USA, LLC, rated "high" severity in Argus HQ's classification: Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Fresenius Kabi USA, LLC has 18 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

How many FDA actions does Argus HQ track for Fresenius Kabi USA, LLC?

22 total: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Fresenius Kabi USA, LLC?

June 17, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Fresenius Kabi USA, LLC had product recalls?

Yes, 22 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Fresenius Kabi USA, LLC official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Related enforcement actions

• Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby Dialysate; Model number: RFP-400-G; →
• Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G,… →
• Fresenius Kabi USA, LLC — Class III recall: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka… →
• Fresenius Kabi USA, LLC — Class II recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: L… →
• Fresenius Kabi USA, LLC — Class I recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 →
• Fresenius Kabi USA, LLC — Class I recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. →
• Fresenius Medical Care Holdings, Inc. — Class II recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… →
• Fresenius Medical Care Holdings, Inc. — Class II recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… →
• Fresenius 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… →
• Fresenius 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… →

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