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Hikma Pharmaceuticals USA INC. FDA Recalls
12 recalls on file across drugs, 1 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottClass IIAug 24, 2026Failed Impurities/Degradation Specifications: OOS result obt |
| Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma PharmaceuClass IIApr 7, 2026This recall is being conducted due to out of specification a |
| Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NClass IIJul 22, 2025Failed Impurities/Degradation Specifications: An out-of-Spec |
| Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, ManClass IJul 8, 2024Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% |
| Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley HeClass IIMar 12, 2024The filter included in the carton has an expiration date tha |
| Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25Class IIMay 11, 2023Failed Impurities/Degradation Specifications: Out-of-specifi |
| Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmClass IIDec 16, 2022Labeling: Label mix-up - one vial was mislabeled as Cladribi |
| Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley HeigClass IIJul 11, 2022Failed Impurities/Degradation Specifications: Out-of-specifi |
| Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-WardClass IIJul 11, 2022Failed Impurities/Degradation Specifications: Out-of-specifi |
| Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 0772Class IIJul 11, 2022Failed Impurities/Degradation Specifications: Out-of-specifi |
| Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley HeigClass IIJul 11, 2022Failed Impurities/Degradation Specifications: Out-of-specifi |
| Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GClass IIIAug 5, 2021Labeling: Not elsewhere classified: Mislabeling |