Hikma Pharmaceuticals USA Inc.
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Hikma Pharmaceuticals USA Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-06FDA-DrugClass IILorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- 2024-08-28FDA-DrugClass IAcetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
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)
- 2024-03-27FDA-DrugClass IIInfumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- 2023-05-24FDA-DrugClass IILorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
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