CLASS II ONGOING Drug recall · Reported 28 May 2025 · FDA Enforcement Report
Airsupra (albuterol and budesonide) inhalation aerosol recalled
AsttraZeneca Pharmaceuticals is recalling Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, distributed nationwide in the US. The recall was initiated on 14 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0444-2025
- FDA event ID
- 96857
- Recalling firm
- AsttraZeneca Pharmaceuticals, Wilmington, DE
- Brand
- Airsupra
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 May 2025
- FDA classified
- 21 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Inhalers & Asthma Medication
Timeline
| 14 May 2025 | Recall initiated by company | |
| 21 May 2025 | Classified by FDA | +7 days |
| 28 May 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective delivery system
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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, .
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Defective delivery system
Which lots are affected?
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 was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Albuterol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | Nationwide |
| Drug | CLASS III | Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Albuterol Sulfate Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Packaging Defects | Nationwide |