The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1307-2022·Announced 2022-08-17

Lorazepam injection vials recalled nationwide for manufacturing specification failures

Hikma Pharmaceuticals is recalling approximately 4.7 million vials of Lorazepam injection nationwide after finding out-of-specification related compounds during quality testing. The affected lots expire between June and August 2023.

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: FDA Class II recall for failed manufacturing specifications with no reported illnesses or injuries. Out-of-specification impurities and degradation products in an injectable benzodiazepine constitute a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Lorazepam injection, USP 2mg/mL is being recalled by Hikma Pharmaceuticals USA Inc. due to failed quality control specifications. Testing of retained samples identified out-of-specification results for total related compounds (impurities and degradation products) in the product.

The recall affects approximately 4.7 million vials distributed nationwide. The affected lot numbers are 060064 (expires June 2023), 070084 (expires July 2023), 070126 (expires July 2023), 080091 (expires August 2023), and 080060 (expires August 2023).

Lorazepam is a prescription injectable benzodiazepine medication. Patients and healthcare providers should verify if they have affected lots and contact their pharmacy or healthcare provider for guidance on replacement or alternative products.

No illnesses or injuries related to this recall have been reported to date.

The recalled product

Product
LORAZEPAM (LORAZEPAM)
Brand
LORAZEPAM
Manufacturer
Hikma Pharmaceuticals USA Inc.
Category
Drug — Injectable benzodiazepine
Hazard
Affected units
4,739,000

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 (8)

  • Lot # 060064
  • Exp. 06/2023
  • 070084
  • Exp. 07/2023
  • 070126
  • 080091
  • Exp. 08/2023
  • 080060

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 →

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