Hikma Pharmaceuticals USA Inc.

10 FDA enforcement actions

10 Total Recalls

1 Class I

8 Class II

1 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 07/22/2025 drug

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class I: Dangerous 07/08/2024 drug

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 II: Risk 03/12/2024 drug

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: Risk 05/11/2023 drug

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: Risk 12/16/2022 drug

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Class II: Risk 07/11/2022 drug

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II: Risk 07/11/2022 drug

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II: Risk 07/11/2022 drug

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II: Risk 07/11/2022 drug

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class III: Low Risk 08/05/2021 drug

Labeling: Not elsewhere classified: Mislabeling

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.