Fresenius Kabi USA Recalls

An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).
- Recalls in database
- 23
- Agency
- FDA
- Years covered
- 2025–2026
This hub covers 6 recall events involving Fresenius Kabi USA, spanning 23 FDA product-line records, published 2025–2026. Fresenius Kabi makes injectable and infusion products; the FDA issues one record per affected product line, so a single recall can appear as many records.
Each row links to the FDA enforcement record with the recall classification and the firm's corrective action.
How this hub is built. This page collects 6 recall events tied to Fresenius Kabi USA (across 23 product-line records) in the current 411 Press recall dataset. A note on counting. The three agencies package recalls differently. NHTSA issues one record per safety campaign; the CPSC issues one per recall; the FDA issues one per affected product line, so a single FDA recall can appear as dozens of records. Counting raw records would push FDA-heavy brands artificially to the top. The counts here are recall EVENTS — distinct agency events — with the FDA product-line record total shown alongside wherever the two differ. Records are grouped by a normalized version of the recalling firm's name (normalizer version 2026-07-28.C3.2). Parent, subsidiary, and "doing business as" relationships are not merged unless the agency data states them, so a corporate family can appear under more than one name. Regulator for these records: FDA. They were published 2025–2026. An event count reflects how much recall activity fell inside the current dataset — not a ranking of relative safety. Larger manufacturers and higher-volume product lines generate more recall activity. This is the current dataset, not an all-time total, and it grows as new notices are ingested. Every row links to the original agency notice.
2026 (22)
- Class II
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
- Class II
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
- Class II
Naropin (ropivacaine hydrochloride Injection, USP)
Presence of Particulate Matter: Hair was found in products
- Class II
Lidocaine HCl Injection
Presence of Particulate Matter: Hair was found in products
- Class II
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
- Class III
Epinephrine Injection
Failed Impurities/Degradations Specifications
- Class I
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
- Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- Class II
5% Dextrose Injection
Lack of Assurance of Sterility
- Class II
5% Dextrose Injection
Lack of Assurance of Sterility
- Class II
5% Dextrose Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.45% Sodium Chloride Injection
Lack of Assurance of Sterility
2025 (1)
- Class I
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.