Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg
Lack of Processing Controls
Is Albuterol recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Albuterol (42 total). Check the affected lots below.
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 on record
none so far in 2026; 42 on record, newest first
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 3.75mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 0.083% Inh Sol. 30 days supply
Lack of Processing Controls.
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Class II · Moderate risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class II · Moderate risk
Combivent Respimat
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class II · Moderate risk
Albuterol Sulfate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Class II · Moderate risk
Albuterol Sulfate ER
Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014.
Class II · Moderate risk
Ventolin HFA
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility
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