The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0856-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Drug — Inhaled Respiratory Medication
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 →

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