Fresenius Kabi USA, LLC: 73 recalls on record

Recalls filed with 1 agency: FDA (73).

First recall on record: July 17, 2013. Most recent: September 2, 2026.

Risk classification: Class I: 16 · Class II: 47 · Class III: 10

Most recent recalls

DateAgencyProduct
April 12, 2017FDAFluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals,…D-0647-2017
February 8, 2017FDAMIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx on…D-0456-2017
June 1, 2016FDAOCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx on…D-0866-2016
June 1, 2016FDAOCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx on…D-0867-2016
April 20, 2016FDACisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injectio…D-0819-2016
August 19, 2015FDAHydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose via…D-1327-2015
July 22, 2015FDARifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Freseniu…D-1234-2015
December 17, 2014FDACYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, R…D-0297-2015
December 17, 2014FDAONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Via…D-0296-2015
December 17, 2014FDAGENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Man…D-0290-2015
December 17, 2014FDAMIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only…D-0295-2015
November 19, 2014FDAHALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, S…D-0247-2015
August 27, 2014FDAPROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pha…D-1545-2014
July 16, 2014FDAFosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium …D-1429-2014
July 16, 2014FDAFosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium eq…D-1428-2014
March 12, 2014FDAHeparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV …D-1148-2014
January 29, 2014FDATranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi U…D-1034-2014
December 25, 2013FDAFOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx …D-379-2014
December 4, 2013FDAPACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(N…D-016-2014
September 4, 2013FDAMagnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single D…D-920-2013
July 24, 2013FDAOxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only…D-804-2013
July 17, 2013FDAFolic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx o…D-688-2013
July 17, 2013FDABenztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx onl…D-685-2013

Questions about this company

How many recalls does Fresenius Kabi USA, LLC have?
Recalert has 73 U.S. recalls on record for Fresenius Kabi USA, LLC, published between July 17, 2013 and September 2, 2026.
Which agencies have handled Fresenius Kabi USA, LLC recalls?
Fresenius Kabi USA, LLC appears as the recalling firm in recalls from: FDA (73).

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