Albuterol recalls

The FDA has published 30 recalls involving Albuterol since 2012. The latest was reported on 22 Apr 2026. Integrated Health Concepts has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls30since 2012

Last 12 months1reported

Class I13% of total

Ongoing6latest 22 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 1May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 1 0May 0 0 0Aug 0 0

Severity split

Class I 1 3%Class II 26 87%Class III 3 10%

Why albuterol is recalled

Companies

Integrated Health Concepts827%
Mckesson Medical-Surgical Inc. Corporate Office413%
GlaxoSmithKline413%
Cardinal Healthcare27%
Cipla USA27%
Nephron Pharmaceuticals27%
Nephron SC13%
AsttraZeneca Pharmaceuticals13%

Brands

By year

202613%
202527%
202427%
202327%
2022413%
202013%
2019827%
2017413%
201613%
201513%

Ongoing albuterol recalls

6 active

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Drug	CLASS II	Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled	Nephron SC	Other	Nationwide
27 Aug 2025Drug	CLASS III	Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate	Cipla USA	Potency & Assay	Nationwide
28 May 2025Drug	CLASS II	Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra	AsttraZeneca Pharmaceuticals	Packaging Defects	Nationwide
7 Jun 2023Drug	CLASS II	Albuterol Sulfate Syrup, 2mg (base) recalled by Akorn	Akorn	Potency & Assay	Nationwide
31 May 2017Drug	CLASS II	Ventolin HFA (albuterol sulfate) Inhalation recalled by GlaxoSmithKlineVentolin	GlaxoSmithKline	Potency & Assay	Nationwide
12 Apr 2017Drug	CLASS II	Ventolin HFA (albuterol sulfate) Inhalation Aerosol recalledVentolin	GlaxoSmithKline	Potency & Assay	Nationwide

All albuterol recalls, newest first

30 total

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Drug	CLASS II	Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled	Nephron SC	Other	Nationwide
27 Aug 2025Drug	CLASS III	Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate	Cipla USA	Potency & Assay	Nationwide
28 May 2025Drug	CLASS II	Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra	AsttraZeneca Pharmaceuticals	Packaging Defects	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
7 Jun 2023Drug	CLASS II	Albuterol Sulfate Syrup, 2mg (base) recalled by Akorn	Akorn	Potency & Assay	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 Solution 0.083%, 2.5 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
15 Jun 2022Drug	CLASS II	Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg 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
27 Nov 2019Drug	CLASS II	Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 2.5mg / Budesonide 0.5mg Vial recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 3.75mg / Ipratropium 0.75mg Vial recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 1.25mg / Ipratropium 0.5mg Vial recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg Vial recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 2.5mg / Ipratropium 0.75mg Vial recalled	Integrated Health Concepts	Other	Nationwide
27 Nov 2019Drug	CLASS II	Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg recalled	Integrated Health Concepts	Other	Nationwide
9 Aug 2017Drug	CLASS III	Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
31 May 2017Drug	CLASS II	Ventolin HFA (albuterol sulfate) Inhalation recalled by GlaxoSmithKlineVentolin	GlaxoSmithKline	Potency & Assay	Nationwide
12 Apr 2017Drug	CLASS II	Ventolin HFA (albuterol sulfate) Inhalation Aerosol recalledVentolin	GlaxoSmithKline	Potency & Assay	Nationwide
1 Feb 2017Drug	CLASS III	Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / Vials recalled	Actavis	Potency & Assay	Nationwide
17 Aug 2016Drug	CLASS II	Albuterol Sulfate Syrup, 2 mg recalled by Teva North America	Teva North America	Particulate Matter	Nationwide
16 Dec 2015Drug	CLASS II	Ventolin HFA (albuterol sulfate) Inhalation Aerosol recalledVentolin	GlaxoSmithKline	Other	MS, VT
29 Jan 2014Drug	CLASS II	Albuterol Sulfate ER, Tablet, 4 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
30 Oct 2013Drug	CLASS II	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg recalledAlbuterol Sulfate	Nephron Pharmaceuticals	Sterility	Nationwide
5 Sep 2012Drug	CLASS II	Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg recalledVentolin	GlaxoSmithKline	Other	Nationwide
15 Aug 2012Drug	CLASS II	Albuterol Sulfate Inhalation Solution recalledAlbuterol Sulfate	Nephron Pharmaceuticals	Sterility	Nationwide

Should you stop taking Albuterol?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.