Labeler · US market

Fresenius Medical Care North America

Fresenius Medical Care North America is a US drug labeler with US FDA registrations covering 2 drug concepts (2 currently active) across 8 packages. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Fresenius Medical Care Holdings, Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes49230

Active drugs2

Registrations4 active / 4

Packages8

Sole supplier of0 drugs

Portfolio2 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride solution	rx	2	4	SUPPLYING
Iron Sucrose injection, solution	rx	2	4	SUPPLYING

At a glance

TypeLabeler
Labeler codes49230
Filing names2
Drugs (active)2
Drugs (all time)2
US registrations4
Packages8

Recent events

Shortages, recalls, and registration changes across all filing names.

Apr 6, 2026
RECALLRecall (Class II): DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, …
Apr 6, 2026
RECALLRecall (Class II): DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, …
Mar 10, 2026
RESOLVEDShortage resolved: Peritoneal Dialysis Solution (Fresenius Medical Care North America)
Mar 10, 2026
SHORTAGEDrug shortage: Peritoneal Dialysis Solution (Fresenius Medical Care North America)
May 27, 2025
RECALLRecall (Class II): 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,…
Jun 18, 2024
RECALLRecall (Class II): DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange S…
Dec 28, 2023
RECALLRecall (Class II): DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Me…
May 23, 2023
RECALLRecall (Class II): Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, W…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.