FDA Drug Recalls

Recalls / Active ingredient / Albuterol Sulfate

Albuterol Sulfate

21 FDA drug recalls involving the active ingredient “Albuterol Sulfate1 Class I.

DateClassProductFirm
2025-07-24Class IIIAlbuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: CiCipla USA, Inc.
2025-05-14Class IIAirsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalAsttraZeneca Pharmaceuticals LP
2024-03-26Class IIIpratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged Cipla USA, Inc.
2023-06-27Class IAlbuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in aCipla USA, Inc.
2022-04-13Class IIAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG bMckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIAlbuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx Mckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIIIpratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count Mckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, ManufMckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIAlbuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, DistriMckesson Medical-Surgical Inc. Corporate Office
2022-01-26Class IIALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured fCARDINAL HEALTHCARE
2022-01-26Class IIIpratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-DCARDINAL HEALTHCARE
2022-01-26Class IIALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only,CARDINAL HEALTHCARE
2020-09-16Class IIAlbuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: CatalentPerrigo Company PLC
2017-05-16Class IIVentolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalGlaxoSmithKline, LLC
2017-03-22Class IIVentolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18GlaxoSmithKline, LLC
2015-12-03Class IIVentolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, GlaxoSmithKline, LLC
2015-08-21Class IIIpratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-DoNephron Pharmaceuticals Corp.
2015-07-24Class IICOMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 GramBoehringer Ingelheim Roxane Inc
2013-10-02Class IIAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL SterilNephron Pharmaceuticals Corp.
2012-07-26Class IIVentolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL IGlaxoSmithKline Inc
2011-06-22Class IIAlbuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL SterilNephron Pharmaceuticals Corp.