Could cause temporary or reversible harm; serious harm is unlikely.
Defective delivery system
| Brand name | AIRSUPRA |
| Generic name | ALBUTEROL SULFATE AND BUDESONIDE |
| Active ingredient(s) | ALBUTEROL SULFATE, BUDESONIDE |
| Distributed by / for | AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France |
| NDC | 0310-9080-12 |
| Full product label | 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 firm | AsttraZeneca Pharmaceuticals LP |
| Distribution | USA Nationwide |
| Quantity | a) 807,837 canisters; b) 235,698 canisters |
| Recall initiated | 2025-05-14 |
| Report date | 2025-05-28 |
| Recall completed | — |
| Recall number | D-0444-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Wilmington DE United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗