Could cause temporary or reversible harm; serious harm is unlikely.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
| Brand name | LORAZEPAM |
| Generic name | LORAZEPAM |
| Active ingredient(s) | LORAZEPAM |
| Distributed by / for | Hikma Pharmaceuticals USA Inc. |
| NDC | 0641-6044-25 |
| Full product label | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 382,775 1mL vials |
| Recall initiated | 2025-07-22 |
| Report date | 2025-08-06 |
| Recall completed | — |
| Recall number | D-0551-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Cherry Hill NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗