Drug recall
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ…
FDA recall event 97294 · Class II · Hikma Pharmaceuticals USA Inc.
Key facts
| Event ID | 97294 |
|---|---|
| Recall numbers | D-0551-2025 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Product type | Drugs |
| Products | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds |
| Initiation date | Jul 22, 2025 |
| Report date | Aug 6, 2025 |
| City | Cherry Hill |
| State | NJ |
| Country | United States |
| FEI number | 2220525 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: