Important Recall Notice for AIRSUPRA Inhalation Aerosol

AstraZeneca Pharmaceuticals LP, the maker of the inhalation medication AIRSUPRA® (albuterol and budesonide) aerosol, has initiated a voluntary recall for their product. This recall is effective immediately and involves multiple product lots. The recalled inhalers might not work properly.

Reason for Recall:

A defect in the delivery system of these inhalers has been identified, which may hinder the proper administration of the medication needed for effective asthma control.

Product Details:

Product Name: AIRSUPRA (albuterol and budesonide) inhalation aerosol 

Strength: 90 mcg/80 mcg per inhalation 

Packaging Types:

120-inhalation canister (NDC 0310-9080-12) 

 28-inhalation canister (NDC 0310-9080-28) 

Recall Number:  D-0444-2025 

Affected Lot Numbers:

For 120-inhalation canisters: Lots: 6270044C00, 6270040D00, 6270034E00, Exp Date 10/2026; 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00 Exp 11/30/2026; 6270064C00, 6270071D00, 6270075D00, 6270075F00 Exp Date 12/31/2026; 6270107C00, Exp Date 9/30/2027  

For 28-inhalation canisters: Lot 6270019E00, Exp Date 7/31/2025; 6270021D00, Exp 8/31/2025; 6270095C00, Exp 2/28/2026

Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France

What You Should Do:

Patients and users are advised not to use the inhalers associated with the affected lots. Please contact your pharmacy or healthcare provider as soon as possible to discuss alternative treatment options. Contact the dispensing pharmacy or AstraZeneca for return processing information.

If you are a current patient of the Oklahoma Allergy and Asthma Clinic affected by this recall, please give us a call at 405-235-0040.  

Recall Contact Information:

For product questions, to report an adverse event or side effect, or to report a product quality issue, you can contact the AstraZeneca Information Center by phone at:

1-800-236-9933 (M-F, 8AM-6PM ET, excluding holidays)

Or you can report a product quality issue online: https://contactazmedical.astrazeneca.com/content/astrazeneca-champion/global/en/amp-form.html

For more information on this recall, please visit: https://www.accessdata.fda.gov/scripts/ires/?Event=96857

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