Class IIOngoing

Lorazepam Injection recall

FDA recall D-0551-2025 · initiated Jul 22, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Recalling company: Hikma Intl Pharms
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed Nationwide in the USA
Initiated: Jul 22, 2025
FDA report date: Aug 6, 2025

This recall is linked to a product we cover: Ativan →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0551-2025 ↗

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