XOPENEX Inhalation Solution Recalled Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification indicates a manufacturing deviation affecting safety and efficacy assurance. However, no illnesses or injuries have been reported, and the hazard is theoretical—incomplete stability studies rather than detected contamination or proven quality failure. This is a precautionary recall to ensure manufacturing compliance.
Plain-English summary
Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate (1.25 mg/3 mL, 0.5 mL unit-dose vials) due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated after Akorn went out of business and could no longer continue the stability studies required to verify the product maintains its safety and effectiveness over time. Stability testing is a critical component of manufacturing compliance to ensure medications remain safe and potent for the duration of their shelf life.
Patients who have this product should consult their healthcare provider about alternative treatments or next steps. Healthcare providers and pharmacists should stop dispensing XOPENEX from this recall and contact their wholesalers for return instructions.
The recalled product
- Product
- XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Hazard
- cgmp-deviation
- incomplete-stability-studies
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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