Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Airsupra (albuterol and budesonide) (Albuterol Sulfate and Budesonide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective delivery system
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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, .
Affected NDCs
0310-9080-12
0310-9080-28
Compare with the code on your package — it is the most precise check available.
Drug: Albuterol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Airsupra Albuterol sulfate and budesonide NDC 00310-9080 |
ALBUTEROL SULFATE 90 ug/1; BUDESONIDE 80 ug/1 | Aerosol, Metered Respiratory (inhalation) |
AstraZeneca Pharmaceuticals LP | Rx |
- Recalling firm
- AsttraZeneca Pharmaceuticals LP
- NDC code
- 0310-9080-12
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0444-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Albuterol recalls
See all
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class II · Moderate risk
Albuterol Sulfate Syrup
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other packaging defect recalls from 2025
All packaging defect recalls
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Carton label: Testosterone Gel 1%
Defective Container - A defect in the side-seal which allows leakage of product.
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
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