July 2025 FDA Recall Lorazepam by Hikma Pharmaceuticals Usa Inc.
D-0551-2025 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on July 22, 2025 for the product Lorazepam. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0551-2025
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
07-22-2025
08-06-2025
382,775 1mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# K24118, exp. date 10/31/2026
