FDA action counts (Argus HQ database)
| Total tracked FDA actions | 6 |
|---|---|
| Recalls | 0 |
| Warning letters | 0 |
| Form 483 inspection citations | 0 |
| Most recent tracked action | Not disclosed in the FDA record. |
| Most severe rating on file | Not disclosed in the FDA record. |
Recall severity breakdown
Computed from all 6 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.
| high | 5 (83.3%) |
|---|---|
| info | 1 (16.7%) |
Recall velocity by month
Months with at least one tracked recall for Fresenius Kabi USA, LLC, oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.
| Month | Recalls |
|---|---|
| 2026-07 | 6 |
Recurring recall-reason patterns
Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”
| Other / not pattern-matched | 5 recalls |
|---|
Full recall history (6)
Most recent first. Every row links to its Argus HQ record and FDA.gov source.
Coverage
No independent news coverage was found for Fresenius Kabi USA, LLC’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.
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Related enforcement actions
Full FDA history for Fresenius Kabi USA, LLC- 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… →
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.govCite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Fresenius Kabi USA, LLC: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/fresenius-kabi-usa-llc
"Fresenius Kabi USA, LLC: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/fresenius-kabi-usa-llc.
Argus HQ Research. "Fresenius Kabi USA, LLC: FDA Enforcement History." Digital Empire Holdings LLC. Accessed September 6, 2026. https://argushq.ai/enforcement/fresenius-kabi-usa-llc.
@misc{argushq_argushq_ai_enforcement_fresenius_kabi_usa_llc_2026,
title = {Fresenius Kabi USA, LLC: FDA Enforcement History},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/enforcement/fresenius-kabi-usa-llc},
note = {Accessed: September 6, 2026}
}