Hikma Pharmaceuticals USA recalls

Hikma Pharmaceuticals USA has 20 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 2 Sep 2026. 5 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls20since 2020

Last 12 months2reported

Class I210% of total

Ongoing5latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 1

Severity split

Class I 2 10%Class II 16 80%Class III 2 10%

Why hikma pharmaceuticals usa is recalled

Product types

Brands

By year

2026210%
202515%
2024210%
2023210%
2022420%
202115%
2020840%

Ongoing hikma pharmaceuticals usa recalls

5 active

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
28 Aug 2024Drug	CLASS I	Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen	Hikma Pharmaceuticals USA	Packaging Defects	OH, PR
27 Mar 2024Drug	CLASS II	Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200	Hikma Pharmaceuticals USA	Sterility	Nationwide

All hikma pharmaceuticals usa recalls, newest first

20 total

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
28 Aug 2024Drug	CLASS I	Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen	Hikma Pharmaceuticals USA	Packaging Defects	OH, PR
27 Mar 2024Drug	CLASS II	Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200	Hikma Pharmaceuticals USA	Sterility	Nationwide
24 May 2023Drug	CLASS II	Lorazepam Injection, USP, 2mg/mL vial recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
4 Jan 2023Drug	CLASS II	Ganciclovir for Injection, USP, 500mg per vial recalledGanciclovir	Hikma Pharmaceuticals USA	Labeling Errors	Nationwide
17 Aug 2022Drug	CLASS II	Lorazepam Injection, USP, 2mg/mL vial, 25 vials recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
17 Aug 2022Drug	CLASS II	Lorazepam Injection, USP, 4mg/mL vial, 25 vial recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
17 Aug 2022Drug	CLASS II	Lorazepam Injection, USP, 2mg/mL vial, 25 vial recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.