Manufacturer
95 recalls in our database name Fresenius Kabi USA, LLC as the manufacturing or recalling firm.
Of the 95 recalls from Fresenius Kabi USA, LLC we have scored against our rubric, 8 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 34 (36%) are Severe.
Which agencies issued them
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Fresenius Kabi is recalling Tyenne (tocilizumab-aazg) injection vials because an internal investigation found the presence of glass particles.
Fresenius Kabi is recalling 625,500 Morphine Sulfate syringes because some were mislabeled and contained Dilaudid instead.
Fresenius Kabi is recalling 92,600 vials of NAROPIN (ropivacaine hydrochloride) injection, 0.5%, 10/2028, due to the presence of particulate matter, including hair, found in the product.
Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.
Fresenius Kabi is recalling lidocaine injection vials after hair was found in the product. The recall affects 181,225 vials distributed nationwide.
FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.
Fresenius Kabi is recalling Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product.
Epinephrine Injection, USP, 1 mg/mL single-dose vials from Fresenius Kabi are being recalled because they failed impurities and degradation specifications. 898,050 vials affected.
Ivenix Infusion System Large Volume Pumps are being recalled because dropping or jarring can loosen the touchscreen input cable, causing random touches or an unresponsive screen.
The Ivenix Infusion System Large Volume Pump software is being recalled because a software anomaly can report a false battery-health value and trigger a shutdown alarm.
The Large Volume Pump of the Ivenix Infusion System is being recalled because of the potential for the Cassette Loading Lever to break. 18,444 installed bases are affected.
Fresenius Kabi USA, LLC is recalling certain batches of 0.9% Sodium Chloride Injection due to concerns regarding sterility assurance.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 100 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 250 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi is recalling one batch of 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 500 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 100 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation, citing lack of assurance of sterility. Two batches are affected.
Fresenius Kabi is recalling 0.45% Sodium Chloride Injection, USP in 250 mL freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling three batches of 5% Dextrose Injection, USP, 5 g per 100 mL in freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 2.5 g per 50 mL supplied in 100 mL freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 12.5 g per 250 mL in freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by Fresenius Medical Care RTG, citing lack of assurance of sterility.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Fresenius Kabi
company based in Bad Homborg, Germany; offers health products for the critically and chronically ill.
Source: Wikidata (Q1455670), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.