Recalling firm
Hikma Pharmaceuticals USA Inc.
Product type
Drug
Status
Ongoing
Report date
2025-08-06
Distribution
Distributed Nationwide in the USA
Firm state
NJ
Product quantity
382,775 1mL vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Product description
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Code / lot info
Lot # K24118, exp. date 10/31/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.