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D-0551-2025Class II

Hikma Pharmaceuticals USA Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 & Qualification
Reason 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. 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. Open the enforcement explorer →