Class II

Drug Recall: Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

Hikma Pharmaceuticals USA Inc. · July 22, 2025

Reason for Recall

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

Distribution

Distributed Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

382,775 1mL vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0551-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hikma Pharmaceuticals USA Inc. Drug Recall: Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 | SafeCheck