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 USA is recalling 93,000 vials of Hydralazine Hydrochloride Injection because the expiration date printed on the secondary packaging is incorrect.
Fresenius Kabi is recalling 7,593 vials of Rifampin for Injection because the product failed impurity and degradation specifications.
Fresenius Kabi is recalling 5,488 bags of KABIVEN IV solution because the label lists 3.1% amino acids, but the product actually contains 3.3%.
Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.
Fresenius Kabi USA is recalling 240,550 vials of Cyanocobalamin Injection due to potential glass fractures and particles that compromise sterility.
Fresenius Kabi USA is recalling 184,550 vials of Ondansetron Injection due to potential glass fractures and particles that compromise sterility.
Fresenius Kabi USA is recalling 101,200 vials of Midazolam Hydrochloride Injection due to potential glass fractures and particles that compromise sterility.
Fresenius Kabi is recalling 92,125 vials of Gentamicin Injection because some may be missing stoppers. The product was distributed nationwide and in Puerto Rico.
Fresenius Kabi is recalling Haloperidol Decanoate Injection vials due to an out-of-specification impurity result. The recall covers 216,517 vials distributed nationwide and in Puerto Rico.
Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection because the active ingredient supplier received citations for critical manufacturing deficiencies.
Fresenius Kabi USA, LLC is recalling Fosphenytoin Sodium Injection vials due to potential glass delamination and particulates.
Fresenius Kabi USA, LLC is recalling 728,880 vials of Fosphenytoin Sodium Injection due to potential glass delamination and particulates.
Fresenius Kabi is recalling Heparin Sodium Injection vials because they may contain less active ingredient than labeled.
Fresenius Kabi USA is recalling 121,456 vials of Tranexamic Acid Injection USP due to the presence of particulate matter consistent with glass vial delamination.
Fresenius Kabi USA is recalling folic acid injection vials due to failed impurity and degradation specifications at 14 and 15 months.
Fresenius Kabi USA, LLC is recalling 71,129 vials of Paclitaxel Injection because the package insert is missing text in the Clinical Studies and Specific Adverse Events sections.
Fresenius Kabi is recalling 15,625 vials of Magnesium Sulfate Injection, USP, 50% due to the presence of glass particulate matter.
Fresenius Kabi is recalling 221,600 vials of Oxytocin Injection, USP, due to a subpotent drug issue identified during a 15-month stability test.
Fresenius Kabi is recalling 65,110 vials of Benztropine Mesylate Injection due to the presence of glass particulate matter. The affected vials were distributed nationwide and in Puerto Rico.
Fresenius Kabi USA is recalling 80,480 vials of Folic Acid Injection due to failed impurities and degradation specifications.
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.