Lorazepam Injection — Class II drug recall D-0551-2025
Ongoing recall by Hikma Pharmaceuticals USA Inc., reported 2025-08-06, distributed nationwide. Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
| Recall number | D-0551-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2025-07-22 |
| Classified | 2025-07-31 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 382,775 |
| Reason classes | specification failure |
| NDC | 00641-6044, 00641-6044-01, 00641-6044-25, 00641-6045, 00641-6045-01, 00641-6045-25, 00641-6046, 00641-6046-01, 00641-6046-10, 00641-6047, 00641-6047-01, 00641-6047-10 |
| Lot numbers | K24118 |
| Expiration dates | 2026-10-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0551-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.