FDA Enforcement History: Fresenius Kabi USA, LLC

FDA action counts

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.

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.

Frequently asked questions

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

July 29, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Fresenius Kabi USA, LLC had product recalls?

Yes, 27 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.

How many FDA actions has Fresenius Kabi USA, LLC had?

Argus HQ has recorded 18 FDA events for Fresenius Kabi USA, LLC: 0 warning letters, 18 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Fresenius Kabi USA, LLC — Class II recall: Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose… →
• Fresenius Kabi USA, LLC — Class II recall: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg… →
• Fresenius Kabi USA, LLC — Class II recall: Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in… →
• Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2… →
• FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified) →
• Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 2… →
• FRESENIUS KABI USA — ANDA approval: SUGAMMADEX SODIUM (unspecified) →
• 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… →

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