Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Is Albuterol recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Albuterol (42 total). Check the affected lots below.
Most common reason: Temperature excursion (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Albuterol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Albuterol recalls in 2026
1 initiated in 2026, 42 in total — newest first
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
Airsupra (albuterol and budesonide)
Defective delivery system
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.
Class II · Moderate risk
Albuterol (Pf/Sulfuric Acid/Dye Free)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Proventil HFA
cGMP deviations: Temperature abuse
Class II · Moderate risk
Proair
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator
cGMP deviations: Temperature abuse
Class III · Low risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution 0.083%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution 0.083%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
ALBUTEROL SULFATE IN 90MCG per actuation
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
ALBUTEROL SULFATE HFA Inhalation Aerosol
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Proair HFA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol
Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg
Lack of Processing Controls
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