Brand

Fresenius Kabi Usa, Llc Recalls

81 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fresenius Kabi Usa, Llc.

81Total Recalls
22Critical
45.3MUnits Affected
Mar 11, 2026Most Recent
All Recalls

Every Fresenius Kabi Usa, Llc Recall

Sorted by most recent. Click any recall for full details.

81 recalls
CriticalFDA
Fresenius Kabi Usa, Llc
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL ...
Injectable Drugs·14,016 affected·Jun 28, 2019
RecallFDA
Fresenius Kabi Usa, Llc
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Injectable Drugs·11,981 affected·May 22, 2019
CriticalFDA
Fresenius Kabi Usa, Llc
SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, I...
Injectable Drugs·1,312,350 affected·Nov 15, 2018
CriticalFDA
Fresenius Kabi Usa, Llc
SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, I...
Injectable Drugs·23,745,300 affected·Nov 15, 2018
RecallFDA
Fresenius Kabi Usa, Llc
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Injectable Drugs·35,620 affected·Jan 16, 2018
CriticalFDA
Fresenius Kabi Usa, Llc
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Freseni...
Injectable Drugs·203,136 affected·Oct 27, 2017
Medium RiskFDA
Fresenius Kabi Usa, Llc
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Injectable Drugs·118,224 affected·Mar 16, 2017
High RiskFDA
Fresenius Kabi Usa, Llc
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 6017...
Injectable Drugs·47 affected·Dec 16, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Sch...
Injectable Drugs·355,150 affected·May 4, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Sch...
Injectable Drugs·40,280 affected·May 4, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60...
Injectable Drugs·69,225 affected·Apr 25, 2016
RecallFDA
Fresenius Kabi Usa, Llc
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Injectable Drugs·48,210 affected·Apr 7, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius ...
Injectable Drugs·94,560 affected·Apr 5, 2016
RecallFDA
Fresenius Kabi Usa, Llc
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Rub...
Injectable Drugs·93,000 affected·Jul 28, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 6...
Injectable Drugs·7,593 affected·Jun 4, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufact...
Injectable Drugs·5,488 affected·Apr 28, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi...
Medical Devices·69,725 affected·Dec 19, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumbur...
Injectable Drugs·92,125 affected·Nov 12, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 6332...
Injectable Drugs·56,060 affected·Aug 13, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manuf...
Injectable Drugs·2,070,500 affected·May 2, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Man...
Injectable Drugs·728,880 affected·May 2, 2014
Medium RiskFDA
Fresenius Kabi Usa Llc
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Injectable Drugs·216,517 affected·Apr 14, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-5...
Injectable Drugs·161,650 affected·Jan 22, 2014
Medium RiskFDA
Fresenius Kabi Usa, Llc
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 6...
Injectable Drugs·215,340 affected·Dec 6, 2013
RecallFDA
Fresenius Kabi Usa, Llc
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for AP...
Injectable Drugs·71,129 affected·Nov 8, 2013
High RiskFDA
Fresenius Kabi Usa, Llc
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for:...
Injectable Drugs·121,456 affected·Oct 31, 2013
High RiskFDA
Fresenius Kabi Usa, Llc
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceu...
Injectable Drugs·65,110 affected·Jul 1, 2013
High RiskFDA
Fresenius Kabi Usa, Llc
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Ph...
Injectable Drugs·221,600 affected·Jun 24, 2013
CriticalFDA
Fresenius Kabi Usa, Llc
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharma...
Injectable Drugs·15,625 affected·May 25, 2013
RecallFDA
Fresenius Kabi Usa, Llc
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60...
Injectable Drugs·80,480 affected·May 21, 2013
High RiskFDA
Fresenius Kabi Usa, Llc
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, I...
Injectable Drugs·240,550 affected·Sep 27, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 6017...
Injectable Drugs·101,200 affected·Sep 27, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumbu...
Injectable Drugs·184,550 affected·Sep 27, 2012