Agency classClass IIOur severity:High FDA (Drugs)·D-1310-2022·Announced 2022-08-17

Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation

Hikma Pharmaceuticals is recalling 82,700 vials of Lorazepam Injection due to failed quality specifications for impurities and degradation. Lot #070096 (expired July 2023) was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical due to failed quality specifications for impurities and degradation. The product represents a risk-of-harm product where injury has not yet been reported, qualifying it as High severity per the rubric.

Plain-English summary

Hikma Pharmaceuticals USA Inc. is recalling approximately 82,700 vials of Lorazepam Injection, USP, 4mg/mL. The affected lot is Lot #070096, which expired in July 2023 and was distributed nationwide in the United States.

The U.S. Food and Drug Administration issued this Class II recall after testing revealed the product failed quality specifications for impurities and degradation. The lorazepam did not meet standards for total related compounds present in the medication.

Out-of-specification impurity and degradation levels in a pharmaceutical can affect product safety and effectiveness. The presence of these issues in tested samples triggered the recall of the entire lot.

Hikma Pharmaceuticals USA Inc. is the manufacturer and recalling firm. The affected product is identified by NDC codes 0641-6045-25 (carton) and 0641-6045-01 (individual vial).

The recalled product

Product: LORAZEPAM (LORAZEPAM)
Brand: LORAZEPAM
Manufacturer: Hikma Pharmaceuticals USA Inc.
Category: Drug — Injectable Benzodiazepine
Hazard: impurities
degradation
Affected units: 82,700

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # 070096
exp. date 07/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Hikma Pharmaceuticals USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same brand · LORAZEPAM

Moderate
Lorazepam injection vials failed the total related compounds impurity specification
FDA (Drugs) · 2025-08-06
High
Lorazepam tablets recalled due to failed potency and impurity specifications
FDA (Drugs) · 2025-02-26
High
Lorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing
FDA (Drugs) · 2025-02-26
High
Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications
FDA (Drugs) · 2025-02-26
High
Lorazepam injection vials recalled for elevated impurities and degradation
FDA (Drugs) · 2023-05-24

Same manufacturer · Hikma Pharmaceuticals USA Inc.

See all →

Moderate
Hikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
Moderate
Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results
FDA (Drugs) · 2026-05-06
Severe
FDA Recalls Acetaminophen Injection Due to Labeling Mix-up
FDA (Drugs) · 2024-08-28
High
Morphine Sulfate Ampuls Recalled for Expired Filters in Cartons
FDA (Drugs) · 2024-03-27
High
Ganciclovir injection vials contain mislabeled cladribine vials in cartons
FDA (Drugs) · 2023-01-04

Same hazard · impurities