Airsupra (albuterol and budesonide) inhalation aerosol recall
FDA recall D-0444-2025 · initiated May 14, 2025
AsttraZeneca Pharmaceuticals LP recalled Airsupra (albuterol and budesonide) inhalation aerosol in May 2025 — an FDA Class II recall (D-0444-2025) because Defective delivery system.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective delivery system
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: a) 807,837 canisters; b) 235,698 canisters
Details
- Product
- Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
- Recalling company
- AsttraZeneca Pharmaceuticals LP
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 14, 2025
- FDA report date
- May 28, 2025
This recall is linked to a product we cover: Airsupra →
Frequently asked
- Was Airsupra (albuterol and budesonide) inhalation aerosol recalled?
- AsttraZeneca Pharmaceuticals LP recalled Airsupra (albuterol and budesonide) inhalation aerosol in May 2025 — an FDA Class II recall (D-0444-2025) because Defective delivery system. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Airsupra (albuterol and budesonide) inhalation aerosol recalled?
- Per the FDA enforcement record, the reason for recall D-0444-2025 was: Defective delivery system
- Is a recalled Airsupra (albuterol and budesonide) inhalation aerosol dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Airsupra (albuterol and budesonide) inhalation aerosol are affected?
- Distributed: USA Nationwide. The recall covers these lots — 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; 6270…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0444-2025.