Hikma Pharmaceuticals recalls
FDA enforcement reports naming Hikma Pharmaceuticals USA INC as the recalling firm.
- Recall reports
- 20
- Class I (serious)
- 2
- Most recent report
- Sep 2, 2026
- Sep 2, 2026Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500…Drug · Hikma Pharmaceuticals USA INC.Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).Class II
- May 6, 2026Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bo…Drug · Hikma Pharmaceuticals USA INCThis recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.Class II
- Aug 6, 2025Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hi…Drug · Hikma Pharmaceuticals USA Inc.Failed Impurities/Degradation Specifications: An out-of-Specification for total related compoundsClass II
- Aug 28, 2024Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For I…Drug · Hikma Pharmaceuticals USA Inc.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 I
- Mar 27, 2024Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only,…Drug · Hikma Pharmaceuticals USA Inc.The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.Class II
- May 24, 2023Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL V…Drug · Hikma Pharmaceuticals USA Inc.Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.Class II
- Jan 4, 2023Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only,…Drug · Hikma Pharmaceuticals USA Inc.Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.Class II
- Aug 17, 2022Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, R…Drug · Hikma Pharmaceuticals USA Inc.Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Class II
- Aug 17, 2022Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufacture…Drug · Hikma Pharmaceuticals USA Inc.Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Class II
- Aug 17, 2022Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Ma…Drug · Hikma Pharmaceuticals USA Inc.Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Class II
- Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Ma…
- Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manuf…
- Sodium Chloride Injection, USP, 0
- Sodium Chloride Injection, USP, 0
- Buprenorphine HCl Injection, 0
- Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoor…
- Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoor…
- methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by:…
- Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC…
- Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Do…
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