# FDA recall D-0551-2025

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2025-07-22.

## 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

## Reason for recall

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

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0551-2025
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-22
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cherry Hill, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0551-2025

## Citation

> AI Analytics. FDA recall D-0551-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0551-2025. Source: US FDA. Licensed CC0.

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