The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0825-2023·Announced 2023-06-07

Lorazepam Injection Recalled Due to Manufacturing Control Deviations

Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL due to CGMP deviations. The firm ceased operations and could not continue required stability studies.

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 a Class II FDA recall for CGMP deviations affecting a parenteral benzodiazepine due to incomplete stability testing. No illnesses or injuries have been reported, making this a theoretical risk-of-harm product situation, which meets the High severity criterion.

Plain-English summary

Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL in 1 mL vials, manufactured by Akorn, Inc. in Lake Forest, Illinois. The product was distributed nationwide in the USA and Puerto Rico. This is a Class II recall.

The recall has been issued due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm went out of business and was unable to continue the stability studies required to verify and maintain the product's integrity and safety throughout its shelf life.

The recalled product

Product
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable Benzodiazepine
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, 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 86 products in this recall →

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