Akorn recalls XOPENEX inhalation solution due to stability concerns after firm went out of business. All units are affected; no remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all XOPEN: 1.25mg/3mL levalbuterol inhalation solution vials because the company went out of business and can no longer ensure product stability. This means the medication may not be safe for use.
The manufacturer went out of business and stopped stability testing, meaning the product's effectiveness and safety could degrade over time. Without ongoing testing, there's a risk of the medication becoming ineffective or unsafe for use.
Prescription users of XOPENEX inhalation solution who received the product from Akorn. Those with chronic respiratory conditions are at higher risk due to potential medication instability.
Check for XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials. All units are affected regardless of lot or batch number.
Identify the product by checking the label for XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials.
The recall notice does not provide a remedy.
All XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials are affected.
The manufacturer went out of business and could no longer continue stability studies, which may affect product safety and effectiveness.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0856-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0856-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
