Albuterol Sulfate recalls

Albuterol Sulfate products have been recalled 9 times, most recently on 27 Aug 2025. The recalling company is usually Cardinal Healthcare. The most common reason is manufacturing (cgmp) deviations.

Total recalls9since 2012

Last 12 months0reported

Class I111% of total

Ongoing1latest 27 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 1 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 1 11%Class II 7 78%Class III 1 11%

Why albuterol sulfate is recalled

Companies

Cardinal Healthcare222%
Cipla USA222%
Mckesson Medical-Surgical Inc. Corporate Office222%
Nephron Pharmaceuticals222%
Perrigo111%

Product types

Inhalers & Asthma Medication9100%

By year

2025111%
2024222%
2023111%
2022222%
2020111%
2013111%
2012111%

Ongoing albuterol sulfate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Drug	CLASS III	Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate	Cipla USA	Potency & Assay	Nationwide

All albuterol sulfate recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Drug	CLASS III	Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate	Cipla USA	Potency & Assay	Nationwide
3 Jan 2024Drug	CLASS II	Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Jan 2024Drug	CLASS II	Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
19 Jul 2023Drug	CLASS I	Albuterol Sulfate Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate	Cipla USA	Packaging Defects	Nationwide
15 Jun 2022Drug	CLASS II	Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg recalledAlbuterol Sulfate	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Albuterol Sulfate Inhalation Aerosol HFA 90 mcg recalledAlbuterol Sulfate	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
30 Sep 2020Drug	CLASS II	Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation recalledAlbuterol Sulfate	Perrigo	Other	Nationwide
30 Oct 2013Drug	CLASS II	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg recalledAlbuterol Sulfate	Nephron Pharmaceuticals	Sterility	Nationwide
15 Aug 2012Drug	CLASS II	Albuterol Sulfate Inhalation Solution recalledAlbuterol Sulfate	Nephron Pharmaceuticals	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.