FDA Drug recall D-0551-2025
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
- FDA Drug
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 by Hikma Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0551-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-22 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Identifiers
| ndc | 0641-6044-01 |
|---|---|
| ndc | 0641-6044-25 |
| ndc | 0641-6046-01 |
| ndc | 0641-6046-10 |
| ndc | 0641-6045-01 |
| ndc | 0641-6045-25 |
| ndc | 0641-6047-01 |
| ndc | 0641-6047-10 |
| code_info | Lot # K24118, exp. date 10/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2023-05-24 · Hikma Pharmaceuticals Usa
All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0551-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.