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Hikma Pharmaceuticals USA Recalls
19 recalls on record · January 22, 2020 to May 6, 2026 · Drugs
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.
May 6, 2026DrugsFDA
Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu
Hazard: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
August 6, 2025DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, N
Hazard: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
August 28, 2024DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Man
Hazard: 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)
March 27, 2024DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He
Hazard: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
May 24, 2023DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
January 4, 2023DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE Gm
Hazard: Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heig
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heig
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 0772
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
September 1, 2021DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie G
Hazard: Labeling: Not elsewhere classified: Mislabeling
December 23, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 0
Hazard: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
November 25, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile dil
Hazard: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
September 2, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:
Hazard: Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
June 24, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2
Hazard: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
June 24, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2
Hazard: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
January 29, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA
Hazard: 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 for Injection with Benzyl Alcohol.
January 22, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pa
Hazard: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
January 22, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 v
Hazard: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)