The Recall Desk
HighFDA (Drugs)·D-0830-2023·Announced 2023-06-07

Naloxone Injection Recall Due to Manufacturing Process Deviations

Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required stability studies.

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 is a risk-of-harm product (essential opioid overdose-reversal medication) where no illnesses or injuries have been reported but stability cannot be verified due to incomplete manufacturing studies.

Plain-English summary

Akorn, Inc. is recalling all lots of Naloxone Injection, USP 0.4 mg/mL in 1 mL vials. The product is distributed nationwide in the United States and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer went out of business and was unable to continue and complete stability studies required to verify the product's shelf life and efficacy.

The recalled product

Product
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable
Hazard
  • stability-concern
  • manufacturing-deviation

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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