Recall
FDAHealthJuly 22, 2025

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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 22, 2025

Distributed Nationwide in the USA

What's affected?

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
Lot code
K24118

Additional details

Lot # K24118, exp. date 10/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 382,775 1mL vials.

View original FDA notice →

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