FDA Recall D-0551-2025
Hikma Pharmaceuticals USA Inc. · Cherry Hill, NJ
Class II Ongoing 296 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0551-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2025-07-22
- Classified by FDA Center
- 2025-07-31
- FDA published
- 2025-08-06
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Firm location
- Cherry Hill, NJ
Drug identification
- Brand name(s)
- LORAZEPAM
- Generic name(s)
- LORAZEPAM
- Manufacturer(s)
- Hikma Pharmaceuticals USA Inc.
- NDC(s)
0641-6044, 0641-6046, 0641-6045, 0641-6047- Route(s)
- INTRAMUSCULAR, INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.