Albuterol is a rescue inhaler medication for asthma. We track every FDA enforcement recall involving Albuterol (Ventolin, ProAir) — 23 recalls in our database, including 4 active.
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Cipla USA, Inc. — 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.
Recall D-0593-2025
AsttraZeneca Pharmaceuticals LP — Defective delivery system
Recall D-0444-2025
Cipla USA, Inc. — Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Recall D-0471-2024
Cipla USA, Inc. — Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Recall D-0938-2023
Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
Recall D-1018-2022
Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
Recall D-1021-2022
Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
Recall D-1024-2022
Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
Recall D-1020-2022
Showing 8 of 23. See all Albuterol recalls.
This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.
The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Albuterol recall is issued.
Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.
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