DrugJul 29, 2026
Naropin recall — FDA D-0727-2026
Presence of Particulate Matter: Hair was found in products
Class IIFDA: OngoingFresenius Kabi USA, LLC
Recall history in this database
Classification mix: Class II: 20, Class I: 3.
DrugJul 29, 2026
Xylocaine recall — FDA D-0728-2026
Presence of Particulate Matter: Hair was found in products
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugJul 29, 2026
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL recall — FDA D-0726-2026
Presence of Particulate Matter: Hair was found in products
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugJul 29, 2026
Xylocaine recall — FDA D-0729-2026
Presence of Particulate Matter: Hair was found in products
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugJul 29, 2026
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL recall — FDA D-0725-2026
Presence of Particulate Matter: Hair was found in product
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceJun 10, 2026
Fresenius Kabi USA The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA Z-2274-2026
Potential for the Cassette Loading Lever to break.
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceJun 10, 2026
Fresenius Kabi USA LVP software of the Ivenix Infusion System (IIS) recall — FDA Z-2223-2026
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…
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceJun 10, 2026
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump recall — FDA Z-2224-2026
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…
Class IFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 recall — FDA D-0427-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL recall — FDA D-0424-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL recall — FDA D-0432-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) recall — FDA D-0426-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 recall — FDA D-0428-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL recall — FDA D-0430-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
DEXTROSE 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL recall — FDA D-0435-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
DEXTROSE 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL recall — FDA D-0437-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
DEXTROSE 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL recall — FDA D-0436-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 recall — FDA D-0433-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 recall — FDA D-0425-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company recall — FDA D-0429-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL recall — FDA D-0431-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugApr 15, 2026
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 recall — FDA D-0434-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingFresenius Kabi USA, LLC
DrugDec 3, 2025
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials recall — FDA D-0182-2026
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class IFDA: OngoingFresenius Kabi USA, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Fresenius Kabi USA, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.