DrugSep 2, 2026
Ramipril Capsules USP, 10 mg recall — FDA D-0831-2026
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class IIFDA: OngoingHikma Pharmaceuticals USA Inc.
Recall history in this database
Classification mix: Class II: 15, Class III: 2, Class I: 2.
DrugMay 6, 2026
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL recall — FDA D-0526-2026
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class IIFDA: OngoingHikma Pharmaceuticals USA INC
DrugAug 28, 2024
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For recall — FDA D-0635-2024
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Class IFDA: OngoingHikma Pharmaceuticals USA Inc.
DrugMar 27, 2024
INFUMORPH 200 Infumorph recall — FDA D-0392-2024
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class IIFDA: OngoingHikma Pharmaceuticals USA Inc.
DrugMay 24, 2023
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01) recall — FDA D-0574-2023
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJan 4, 2023
Ganciclovir for Injection, USP, 500mg per vial recall — FDA D-0090-2023
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugAug 17, 2022
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton recall — FDA D-1308-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugAug 17, 2022
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton recall — FDA D-1309-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugAug 17, 2022
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton recall — FDA D-1310-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugAug 17, 2022
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton recall — FDA D-1307-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugSep 1, 2021
Bleomycin for Injection, USP recall — FDA D-0771-2021
Labeling: Not elsewhere classified: Mislabeling
Class IIIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugDec 23, 2020
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial recall — FDA D-0169-2021
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugNov 25, 2020
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative recall — FDA D-0101-2021
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugSep 2, 2020
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only recall — FDA D-1533-2020
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJun 24, 2020
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials recall — FDA D-1308-2020
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJun 24, 2020
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials recall — FDA D-1309-2020
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJan 29, 2020
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial recall — FDA D-0801-2020
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water…
Class IIIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJan 22, 2020
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL) recall — FDA D-0658-2020
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJan 22, 2020
Ketorolac Tromethamine Injection, USP 30 mg/mL recall — FDA D-0864-2020
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class IFDA: TerminatedHikma Pharmaceuticals USA Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Hikma Pharmaceuticals USA Inc. 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.