The Recall Desk
HighFDA (Drugs)·D-0828-2023·Announced 2023-06-07

Midazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues

Akorn, Inc. is recalling all lots of Midazolam Injection USP 2mg/2mL nationwide because the manufacturer went out of business and cannot complete required stability studies mandated by Current Good Manufacturing Practice regulations.

What this means for you

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 of an injectable medication due to Current Good Manufacturing Practice deviations and incomplete stability studies. This is a risk-of-harm product (injectable drug) where the long-term stability profile is unknown. Although no adverse events have been reported, injectable drugs with unknown stability represent a potential patient safety concern.

Plain-English summary

Akorn, Inc. is recalling all lots of Midazolam Injection, USP 2mg/2mL (1 mg/mL) for intramuscular or intravenous use. The product is supplied in 2mL vials and is a prescription-only injectable medication manufactured by Akorn, Inc. in Lake Forest, Illinois.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer ceased operations and can no longer continue the stability studies that are required by federal regulation to ensure the drug remains safe and effective throughout its shelf life. Stability studies are critical for injectable drugs to verify that the product maintains its strength, quality, and safety over time.

The recalled medication was distributed nationwide in the USA and Puerto Rico. Patients who have received this product and healthcare providers who have it in inventory should be aware of this recall.

Patients should not stop taking their medication without consulting their healthcare provider. Healthcare facilities and pharmacies should immediately check their inventory for the recalled product and take appropriate action. Questions about this recall should be directed to the FDA.

The recalled product

Product
Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable medication
Hazard
  • cgmp-deviation
  • incomplete-stability-testing

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.

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