Recalls / Class II
Class IID-0551-2025
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
- Brand name
- Lorazepam
- Generic name
- Lorazepam
- Active ingredient
- Lorazepam
- Route
- Intramuscular, Intravenous
- NDCs
- 0641-6044, 0641-6046, 0641-6045, 0641-6047
- FDA application
- NDA018140
- Affected lot / code info
- Lot # K24118, exp. date 10/31/2026
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 382,775 1mL vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-07-22
- FDA classified
- 2025-07-31
- Posted by FDA
- 2025-08-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0551-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.