Hikma Pharmaceuticals USA Inc.

FDA Regulatory Profile

Summary

Total Recalls
18 (2 Class I)
510(k) Clearances
0
Inspections
55
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-0551-2025Class IILorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley July 22, 2025
D-0635-2024Class IAcetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous UsJuly 8, 2024
D-0392-2024Class IIInfumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured March 12, 2024
D-0574-2023Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per cartMay 11, 2023
D-0090-2023Class IIGanciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYDecember 16, 2022
D-1308-2022Class IIAtivan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, ManufJuly 11, 2022
D-1307-2022Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-WarJuly 11, 2022
D-1309-2022Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured byJuly 11, 2022
D-1310-2022Class IILorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured byJuly 11, 2022
D-0771-2021Class IIIBleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by ThAugust 5, 2021
D-0169-2021Class IISodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-December 7, 2020
D-0101-2021Class IISodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For November 3, 2020
D-1533-2020Class IIBuprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx OnlAugust 14, 2020
D-1309-2020Class IIIrinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan PharmazieJune 11, 2020
D-1308-2020Class IIIrinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan PharmazieJune 11, 2020
D-0801-2020Class IIImethylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEJanuary 14, 2020
D-0864-2020Class IKetorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01December 17, 2019
D-0658-2020Class IIKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDCDecember 17, 2019