Fresenius Kabi USA, LLC recalls
31 recalls filed under Fresenius Kabi USA, LLC. The most recent was published September 2, 2026.
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Class I · last month
Fresenius Kabi USA, LLC Tyenne Injection, 400 mg/20 mL , 20 mL vial recall: Presence of particulate matter:An internal investigation at the firm found
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Class I · 2 months ago
Fresenius Kabi USA, LLC Morphine Sulfate Injection, USP, 2 mg /mL recall: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
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Class II · 3 months ago
Fresenius Kabi USA, LLC Glycopyrrolate Injection, USP, 1 mg per 5 mL recall: Presence of Particulate Matter: Hair was found in product
Presence of Particulate Matter: Hair was found in product
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Class II · 3 months ago
Fresenius Kabi USA, LLC Xylocaine , 1%, 500 mg per 50 mL , 25 Multiple-Dose Vials recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
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Class II · 3 months ago
Fresenius Kabi USA, LLC Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
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Class II · 3 months ago
Fresenius Kabi USA, LLC Xylocaine , 1%, 200 mg per 20 mL , 25 Multiple-Dose Vials recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
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Class II · 3 months ago
Fresenius Kabi USA, LLC Naropin , 0.5%, 100 mg per 20 mL , Twenty-five recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
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Class III · 4 months ago
Fresenius Kabi USA, LLC Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial recall: Failed Impurities/Degradations Specifications
Failed Impurities/Degradations Specifications
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Class I · 5 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Fresenius Kabi has been made aware via customer complaints that dropping
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components…
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Class I · 5 months ago
Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System recall: Potential software anomaly that can cause the pump to report a false
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that…
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Class II · 5 months ago
Fresenius Kabi USA, LLC The Large Volume Pump of the Ivenix Infusion System recall: Potential for the Cassette Loading Lever to break
Potential for the Cassette Loading Lever to break.
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL , 1 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 250 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP 0.9% 50 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 1 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 5% Dextrose Injection, USP 5 g per 100 mL 100 mL in a 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 5% Dextrose Injection, USP 12.5 g per 250 mL 250 mL in a 250 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 5% Dextrose Injection, USP 2.5 g per 50 mL 50 mL in a 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL 500 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
About this page
Fresenius Kabi USA, LLC appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.