Has Fresenius Kabi USA, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 27 recalls, 2 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-29; Argus observed and indexed it on 2026-08-04.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · drug_recall · high

Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2…

Name: FDA Recall Record — Fresenius Kabi USA, LLC
Creator: Argus HQ
Published: 2026-07-29
License: https://argushq.ai/methodology

Event date: 2026-07-29 00:00:00Z
Observed: 2026-08-04 04:20:45Z
Source ID: D-0728-2026
Payload hash: cf12e307f7e98042a417fb1e…

Summary

Presence of Particulate Matter: Hair was found in products Status: Ongoing.

Entities

Fresenius Kabi USA, LLC

View source record ↗

Frequently asked questions

Has Fresenius Kabi USA, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 27 recalls, 2 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-29; Argus observed and indexed it on 2026-08-04.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-fresenius-kabi-usa-llc-d-0728-2026

MLA

"Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-fresenius-kabi-usa-llc-d-0728-2026.

Chicago

Argus HQ Research. "Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2…." Digital Empire Holdings LLC. Accessed August 4, 2026. https://argushq.ai/events/fda-recall-fresenius-kabi-usa-llc-d-0728-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_fresenius_kabi_usa_llc_d_0728_2026_2026,
  title = {Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-fresenius-kabi-usa-llc-d-0728-2026},
  note = {Accessed: August 4, 2026}
}

Informational only. Not legal, financial, or medical advice.