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Fresenius Kabi USA Recalls
93 recalls on record · July 17, 2013 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 24, 2019DrugsFDA
Fresenius Kabi USA, LLC recalls Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,
Hazard: Presence of Particulate Matter; glass particulates
June 19, 2019DrugsFDA
Fresenius Kabi USA, LLC recalls Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 6332
Hazard: Failed Impurities/Degradation Specifications.
December 12, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,
Hazard: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
December 12, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,
Hazard: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
February 7, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India,
Hazard: Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
January 10, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton,
Hazard: Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
April 12, 2017DrugsFDA
Fresenius Kabi USA, LLC recalls Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC
Hazard: Subpotent Drug
February 8, 2017DrugsFDA
Fresenius Kabi USA, LLC recalls MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Sc
Hazard: Failed Impurities/Degradation Specifications
June 22, 2016DrugsFDA
Fresenius Kabi USA, LLC recalls Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, L
Hazard: Presence of Particulate Matter: Glass particulate found in sterile injectable product
June 1, 2016DrugsFDA
Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius K
Hazard: Failed Impuities/Degradation Specifications
June 1, 2016DrugsFDA
Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius K
Hazard: Failed Impuities/Degradation Specifications
April 20, 2016DrugsFDA
Fresenius Kabi USA, LLC recalls Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx
Hazard: Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
April 20, 2016DrugsFDA
Fresenius Kabi USA, LLC recalls Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-
Hazard: Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
August 19, 2015DrugsFDA
Fresenius Kabi USA, LLC recalls Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Ka
Hazard: Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
July 22, 2015DrugsFDA
Fresenius Kabi USA, LLC recalls Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, L
Hazard: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
June 10, 2015DrugsFDA
Fresenius Kabi USA, LLC recalls KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], R
Hazard: Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
February 4, 2015Medical DevicesFDA
Fresenius Kabi USA, LLC recalls HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only
Hazard: The lot failed pH specification.
December 17, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, L
Hazard: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
December 17, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceutica
Hazard: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
December 17, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Sc
Hazard: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
December 17, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceutical
Hazard: Defective Container: Vials may be missing stoppers.
November 19, 2014DrugsFDA
Fresenius Kabi USA LLC recalls HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-
Hazard: Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
August 27, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, I
Hazard: CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
July 16, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use V
Hazard: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
July 16, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Via
Hazard: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
March 12, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls 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
Hazard: Subpotent; 18 month time point
January 29, 2014DrugsFDA
Fresenius Kabi USA, LLC recalls Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two la
Hazard: Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
December 25, 2013DrugsFDA
Fresenius Kabi USA, LLC recalls FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC;
Hazard: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
December 4, 2013DrugsFDA
Fresenius Kabi USA, LLC recalls PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Man
Hazard: Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
September 4, 2013DrugsFDA
Fresenius Kabi USA, LLC recalls Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative
Hazard: Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.