Class II · Moderate risk Ongoing
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Lorazepam Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
What was recalled
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- NDC code
- 0641-6044-25
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0551-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lorazepam recalls
See all
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Terminated
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
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