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

FDA recall notice · announced August 6, 2025 · Hikma Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot # K24118, exp. date 10/31/2026
Quantity: 382,775 1mL vials
Status: Ongoing
Products in this recall event:
- Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 (D-0551-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.