FDA Recall D-0444-2025

AsttraZeneca Pharmaceuticals LP · Wilmington, DE

Class II Ongoing 365 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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, .

Lot / code: 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

Quantity: a) 807,837 canisters; b) 235,698 canisters

Reason for recall

Defective delivery system

Recall record

Recall number: D-0444-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-05-14
Classified by FDA Center: 2025-05-21
FDA published: 2025-05-28
Recalling firm: AsttraZeneca Pharmaceuticals LP
Firm location: Wilmington, DE

Drug identification

Brand name(s): AIRSUPRA
Generic name(s): ALBUTEROL SULFATE AND BUDESONIDE
Manufacturer(s): AstraZeneca Pharmaceuticals LP
NDC(s): 0310-9080
Route(s): RESPIRATORY (INHALATION)

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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