Recalls / Class II
Class IID-0444-2025
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, .
- Brand name
- Airsupra
- Generic name
- Albuterol Sulfate And Budesonide
- Active ingredients
- Albuterol Sulfate, Budesonide
- Route
- Respiratory (inhalation)
- NDC
- 0310-9080
- FDA application
- NDA214070
- Affected lot / code info
- 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
Why it was recalled
Defective delivery system
Recalling firm
- Firm
- AsttraZeneca Pharmaceuticals LP
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1800 Concord Pike, N/A, Wilmington, Delaware 19897-0001
Distribution
- Quantity
- a) 807,837 canisters; b) 235,698 canisters
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-05-14
- FDA classified
- 2025-05-21
- Posted by FDA
- 2025-05-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0444-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.