Hikma Pharmaceuticals USA Inc.

Complete recall history across all FDA and CPSC categories — 18 total recalls

Hikma Pharmaceuticals USA Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (18)

FDA drug safety enforcement actions by Hikma Pharmaceuticals USA Inc.

Date Product Reason Class
Jul 22, 2025 Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactur... Failed Impurities/Degradation Specifications: An out-of-Specification for tot... Class II
Jul 8, 2024 Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride ... Class I
Mar 12, 2024 Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... The filter included in the carton has an expiration date that has expired pri... Class II
May 11, 2023 Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 2... Failed Impurities/Degradation Specifications: Out-of-specification results fo... Class II
Dec 16, 2022 Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg... Class II
Jul 11, 2022 Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, M... Failed Impurities/Degradation Specifications: Out-of-specification results ob... Class II
Jul 11, 2022 Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... Failed Impurities/Degradation Specifications: Out-of-specification results ob... Class II
Jul 11, 2022 Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... Failed Impurities/Degradation Specifications: Out-of-specification results ob... Class II
Jul 11, 2022 Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per... Failed Impurities/Degradation Specifications: Out-of-specification results ob... Class II
Aug 5, 2021 Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx o... Labeling: Not elsewhere classified: Mislabeling Class III
Dec 7, 2020 Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, ... Failed pH Specifications: Out of Specification pH Test Results were found in ... Class II
Nov 3, 2020 Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, ... Failed pH Specifications: Out of Specification pH Test Results were found in ... Class II
Aug 14, 2020 Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... Sub-potent Drug: Out-of-Specification assay results found at 3 month stabilit... Class II
Jun 11, 2020 Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... Defective Container: Customer complaints received of a crimp defect while rem... Class II
Jun 11, 2020 Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... Defective Container: Customer complaints received of a crimp defect while rem... Class II
Jan 14, 2020 methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare... Class III
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... Presence of Particulate Matter: particles identified as polydimethylsiloxane ... Class I
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... Presence of Particulate Matter: particles identified as polydimethylsiloxane ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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