Lorazepam Injection
FDA Recall NDC 0641-6044
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Lorazepam (NDC 0641-6044). A significant event, classified as Class II, was initiated on Jul 22, 2025 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Jul 22, 2025
Aug 06, 2025
382,775 1mL vials
Recall Profile & Regulatory Data
Event ID
97294
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Batch or Lot Expiration Information
Lot# K24118, exp. date 10/31/2026
Affected Packages Involved in this Recall
0641-6044-01Product
0641-6044-25Product
0641-6046-01Product
0641-6046-10Product
0641-6045-01Product
0641-6045-25Product
0641-6047-01Product
0641-6047-10Product
Class II Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
May 11, 2023
May 24, 2023
1,352,475 vials
Recall Profile & Regulatory Data
Event ID
92320
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Dec 12, 2023
Product Description
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Batch or Lot Expiration Information
Lot# Lots: 070086, 070128, Exp. 07/2023
Affected Packages Involved in this Recall
0641-6044-01Product
0641-6044-25Product
0641-6046-01Product
0641-6046-10Product
0641-6045-01Product
0641-6045-25Product
0641-6047-01Product
0641-6047-10Product
Class II Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Jul 11, 2022
Aug 17, 2022
4,739,000 vials
Recall Profile & Regulatory Data
Event ID
90583
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 14, 2023
Product Description
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
Batch or Lot Expiration Information
Lot# 060064, Exp. 06/2023, 070084, Exp. 07/2023, 070126, Exp. 07/2023, 080091, Exp. 08/2023, 080060, Exp. 08/2023
Affected Packages Involved in this Recall
0641-6044-01Product
0641-6044-25Product
0641-6046-01Product
0641-6046-10Product
0641-6045-01Product
0641-6045-25Product
0641-6047-01Product
0641-6047-10Product
Class II Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Jul 11, 2022
Aug 17, 2022
82,700 vials
Recall Profile & Regulatory Data
Event ID
90583
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 14, 2023
Product Description
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Batch or Lot Expiration Information
Lot# 070096, exp. date 07/2023
Affected Packages Involved in this Recall
0641-6044-01Product
0641-6044-25Product
0641-6046-01Product
0641-6046-10Product
0641-6045-01Product
0641-6045-25Product
0641-6047-01Product
0641-6047-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
