AIRSUPRA Albuterol and Budesonide Inhalation Aerosol Recalled for Defective Delivery System
AstraZeneca is recalling AIRSUPRA (albuterol sulfate and budesonide) inhalation aerosol due to a defective delivery system. The recall affects multiple lot numbers and expiration dates distributed nationwide.
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 3/5 (High).
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 an FDA Class II recall of a respiratory drug with a defective delivery system that could impair effective medication delivery. Although no illnesses or injuries are explicitly reported in the source, the hazard directly affects a risk-of-harm product (asthma/COPD maintenance therapy), meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AstraZeneca Pharmaceuticals LP is recalling AIRSUPRA (albuterol sulfate and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, due to a defective delivery system. The recall involves approximately 807,837 units of the 120-inhalation canister (NDC 0310-9080-12) and approximately 235,698 units of the 28-inhalation canister (NDC 0310-9080-28).
The affected product was manufactured by AstraZeneca Dunkerque Production in France and distributed nationwide in the USA. Multiple lot numbers with varying expiration dates from July 2025 through September 2027 are included in this recall.
Patients currently using affected AIRSUPRA inhalers should contact their healthcare provider or pharmacist for assistance. Consumers with affected product should not discontinue use of their asthma or COPD medication without consulting their healthcare provider, as this could result in serious health consequences.
The recalled product
- Product
- AIRSUPRA (ALBUTEROL SULFATE AND BUDESONIDE)
- Brand
- AIRSUPRA
- Manufacturer
- AsttraZeneca Pharmaceuticals LP
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 (20)
- Lot#: a) 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
- b) Lot 6270019E00
- Exp Date 7/31/2025
- 6270021D00
- Exp 8/31/2025
Distribution
Distributed nationwide across the United States.
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