FDA Drugs recall ·
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only… recall
- Recall number
- D-0551-2025
- Date
- (initiated July 22, 2025)
- Company / brand
- Hikma Pharmaceuticals USA INC.
2 Esterbrook Ln, Cherry Hill, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 382,775 1mL vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # K24118, exp. date 10/31/2026
Distribution
Distributed Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0551-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.