Hikma Pharmaceuticals USA recalls

Hikma Pharmaceuticals USA has 21 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 28 Oct 2026. 6 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls21since 2020

Last 12 months3reported

Class I210% of total

Ongoing6latest 28 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 1 0Sep 0 0 0Dec 0 0 0Mar 0 1 0Jun 0 0 1Sep 1 0

Severity split

Class I 2 10%Class II 17 81%Class III 2 10%

Why hikma pharmaceuticals usa is recalled

Product types

Brands

By year

2026314%
202515%
2024210%
2023210%
2022419%
202115%
2020838%

Ongoing hikma pharmaceuticals usa recalls

6 active

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Drug	CLASS II	Abirtega (abiraterone acetate) USP, 250 mg recalledAbirtega	Hikma Pharmaceuticals USA	Other	Nationwide
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	Other	Nationwide

All hikma pharmaceuticals usa recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Drug	CLASS II	Abirtega (abiraterone acetate) USP, 250 mg recalledAbirtega	Hikma Pharmaceuticals USA	Other	Nationwide
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	Other	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
17 Aug 2022Drug	CLASS II	Ativan Injection (lorazepam injection, USP), 2mg/mL vial recalled	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
1 Sep 2021Drug	CLASS III	Bleomycin for Injection recalled by Hikma Pharmaceuticals USABleomycin	Hikma Pharmaceuticals USA	Labeling Errors	Nationwide
23 Dec 2020Drug	CLASS II	Sodium Chloride Injection recalled by Hikma Pharmaceuticals USASodium Chloride	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
25 Nov 2020Drug	CLASS II	Sodium Chloride Injection recalled by Hikma Pharmaceuticals USASodium Chloride	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
2 Sep 2020Drug	CLASS II	Buprenorphine HCl Injection, 0.3 mg/mL vial recalledBuprenorphine Hydrochloride	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS II	Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride	Hikma Pharmaceuticals USA	Other	Nationwide
24 Jun 2020Drug	CLASS II	Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride	Hikma Pharmaceuticals USA	Other	Nationwide
29 Jan 2020Drug	CLASS III	methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial recalledMethylprednisolone Sodium Succinate	Hikma Pharmaceuticals USA	Other	Nationwide
22 Jan 2020Drug	CLASS I	Ketorolac Tromethamine Injection, USP 30 mg/mL recalledKetorolac Tromethamine	Hikma Pharmaceuticals USA	Particulate Matter	Nationwide
22 Jan 2020Drug	CLASS II	Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalledKetorolac Tromethamine	Hikma Pharmaceuticals USA	Particulate Matter	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.