Fresenius Kabi USA, LLC
Drug manufacturer · New York
Fresenius Kabi USA, LLC, based in New York, has 1 FDA recall on file.
FDA record
Recent FDA actions
Questions about Fresenius Kabi USA, LLC
No warning letter naming Fresenius Kabi USA, LLC is on file. FDA has published 1 recall naming it.
Yes. FDA's enforcement reports list 1 recall by Fresenius Kabi USA, LLC; the latest, reported on 2026-09-02, is a Class I recall.
Fresenius Kabi USA, LLC is based in New York. The address is the one on its FDA records, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Fresenius Kabi USA, LLC; every record links to the source, and nothing here is advice.
See the rest of this profile
A free account shows the trial list, the financials and the fundraising filings. Pro adds a watchlist: one email when FDA acts on a company you name.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
Approve Suite is not affiliated with Fresenius Kabi USA, LLC.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.