Drugs & medicalClass II

Hikma Pharmaceuticals USA Inc. recalls Lorazepam 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…

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

Read the official notice →
Date
2023-05-24
Country
United States
Brand
Hikma Pharmaceuticals
Product
Lorazepam 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,…
Classification
Class II
Units
Nationwide in the USA and Puerto Rico
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Hikma Pharmaceuticals recalls

  1. 2026-05-06
  2. US
    Drugs & medicalClass II

    Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA…

    This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

    FDA · DrugHikma Pharmaceuticals USA INCUS Nationwide.Official notice →
  3. 2025-08-06
  4. US
    Drugs & medicalClass II

    Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC#…

    Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

    FDA · DrugHikma Pharmaceuticals USA Inc.Distributed Nationwide in the USAOfficial notice →
  5. 2024-08-28
  6. US
    Drugs & medicalClass I

    Hikma Pharmaceuticals USA Inc. recalls Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured…

    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)

    FDA · DrugHikma Pharmaceuticals USA Inc.OH and PROfficial notice →
  7. 2024-03-27
  8. US
    Drugs & medicalClass II

    Hikma Pharmaceuticals USA Inc. recalls Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ…

    The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

    FDA · DrugHikma Pharmaceuticals USA Inc.Nationwide within the United StatesOfficial notice →
  9. 2023-01-04
  10. US
    Drugs & medicalClass II

    Hikma Pharmaceuticals USA Inc. recalls Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH,…

    Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

    FDA · DrugHikma Pharmaceuticals USA Inc.USA NationwideOfficial notice →
  11. 2022-08-17
  12. US
    Drugs & medicalClass II

    Hikma Pharmaceuticals USA Inc. recalls Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward…

    Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

    FDA · DrugHikma Pharmaceuticals USA Inc.Nationwide in the USAOfficial notice →
All 8 Hikma Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2023-05-24
  2. US
  3. US
    Drugs & medicalClass II

    RemedyRepack Inc. recalls Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc.,…

    CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

    FDA · DrugRemedyRepack Inc.Product was distrituded to three direct account in PA.Official notice →
  4. US
    Drugs & medicalClass II

    Sanofi-Aventis U.S. LLC recalls Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A…

    Lack of Assurance of Sterility: Malformed crimped collar seal

    FDA · DrugSanofi-Aventis U.S. LLCNationwide in the USAOfficial notice →
  5. 2023-05-18
  6. US
    Drugs & medical

    Acme United Recalls PhysiciansCare Brand Allergy Relief and Cold and Cough Tablets Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold…

    The recalled products contain diphenhydramine hydrochloride and acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not…

    CPSCAcme United, of Rocky Mount, North CarolinaAbout 2,400Official notice →
  7. 2023-05-17
  8. US
    Drugs & medicalClass II

    CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF:…

    Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload…

    FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.Official notice →
  9. US
    Drugs & medicalClass II

    Merit Medical Systems, Inc. recalls COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

    Custom sheath Introducer contains incorrect needle size

    FDA · DeviceMerit Medical Systems, Inc.US Distribution to state of: MinnesotaOfficial notice →
See all drugs & medical recalls →