Recall: D-0551-2025

Class II - Potentially Harmful

Class IIClassification

2025-07-22Initiated

OngoingStatus

Hikma Pharmaceuticals USA Inc.Firm

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

Reason

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

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.