Fresenius Kabi USA recalls

Fresenius Kabi USA has 95 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 2 Sep 2026. 44 are still ongoing. 31 were reported in the last 12 months. The most frequent reason is particulate matter.

Total recalls95since 2013

Last 12 months31reported

Class I2627% of total

Ongoing44latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 1Feb 0 0 0May 1 0 4Aug 0 0 1Nov 4 1 0Feb 0 14 0May 4 5 1Aug 1 0

Severity split

Class I 26 27%Class II 57 60%Class III 12 13%

Why fresenius kabi usa is recalled

Product types

Brands

By year

20262627%
20251213%
202455%
202366%
202222%
202144%
202077%
201922%
201844%
201722%

Ongoing fresenius kabi usa recalls

44 active

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS I	Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne	Fresenius Kabi USA	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
29 Jul 2026Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide

All fresenius kabi usa recalls, newest first

95 total

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS I	Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne	Fresenius Kabi USA	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
29 Jul 2026Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Naropin (ropivacaine hydrochloride Injection, USP) recalledNaropin	Fresenius Kabi USA	Particulate Matter	Nationwide
17 Jun 2026Drug	CLASS III	Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine	Fresenius Kabi USA	Potency & Assay	Nationwide
10 Jun 2026Device	CLASS I	Ivenix Infusion System (IIS), Large Volume Pump recalled	Fresenius Kabi USA	Device Malfunction	21 states
10 Jun 2026Device	CLASS I	LVP software of the Ivenix Infusion System (IIS); Product Code recalled	Fresenius Kabi USA	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recalled	Fresenius Kabi USA	Device Malfunction	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP 900 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP, 900 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP x60, Becton, Dickson recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP 0.9% (450 mg per (9 mg per mL) recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP, 900 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP, 900 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP, (4,500 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP, 0.9% (900 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP 900 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.45% Sodium Chloride Injection, USP per (4.5 mg per mL) recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP, (2,250 mg recalledSodium Chloride	Fresenius Kabi USA	Sterility	Nationwide
21 Jan 2026Device	CLASS II	Ivenix Infusion System (IIS), LVP recalled by Fresenius Kabi USA	Fresenius Kabi USA	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS I	Ivenix Infusion System (IIS), LVP recalled by Fresenius Kabi USA	Fresenius Kabi USA	Device Malfunction	20 states
10 Dec 2025Device	CLASS I	Ivenix Infusion System, Lvp Primary Administration Set recalled	Fresenius Kabi USA	Other	Nationwide
10 Dec 2025Device	CLASS II	Ivenix Infusion System (IIS), Large Volume Pump recalled	Fresenius Kabi USA	Device Malfunction	Nationwide
3 Dec 2025Drug	CLASS I	Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine	Fresenius Kabi USA	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.