Why it was recalled
Defective delivery system
Product description
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, .
Lot numbers, UPCs & expiration codes
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; 6270095C00, Exp 2/28/2026
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0444-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 14, 2025
- FDA report date
- May 28, 2025
- Quantity
- a) 807,837 canisters; b) 235,698 canisters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AsttraZeneca Pharmaceuticals LP
Original FDA data
Every field from FDA enforcement report D-0444-2025, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Ongoing
- Country
- United States
- Event ID
- 96857
- Address
- 1800 Concord Pike
- Code information
- 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; 6270095C00, Exp 2/28/2026
- Postal code
- 19897-0001
- Report date
- May 28, 2025
- Product type
- Drugs
- Recall number
- D-0444-2025
- Classification
- Class II
- Recalling firm
- AsttraZeneca Pharmaceuticals LP
- Product quantity
- a) 807,837 canisters; b) 235,698 canisters
- Reason for recall
- Defective delivery system
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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, .
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 14, 2025
- Initial firm notification
- Letter
- Center classification date
- May 21, 2025