The Recall Desk
HighFDA (Drugs)·D-0859-2023·Announced 2023-06-07

Akorn Midazolam Injection Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Midazolam Injection nationwide due to manufacturing practice deviations. The company ceased operations and could not complete stability studies to verify the drug's safety and efficacy.

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: This FDA Class II recall involves a high-risk injectable drug where the manufacturer's closure prevented completion of required stability studies. While no illnesses have been reported, the inability to verify drug stability and efficacy for a sedative injectable represents a risk-of-harm situation meeting the Score 3 criterion.

Plain-English summary

Akorn, Inc. is recalling all lots of Midazolam Injection, USP 50 mg/10 mL (5 mg/mL) for intramuscular or intravenous use. The recall covers all lots and affects distributions nationwide in the USA and Puerto Rico.

The FDA has classified this as a Class II recall due to Good Manufacturing Practice (CGMP) deviations. Akorn ceased business operations and could no longer continue the stability studies required to verify that the medication maintains its intended safety and efficacy throughout its shelf life.

The recalled product

Product
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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 →

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · stability unverified

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