Inhalers & Asthma Medication recalls

The FDA has published 95 recalls involving inhalers & asthma medication since 2012. The latest was reported on 17 Jun 2026. Most were for manufacturing (cgmp) deviations. Mckesson Medical-Surgical Inc. Corporate Office 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 recalls95since 2012

Last 12 months2reported

Class I44% of total

Ongoing13latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 4 4%Class II 75 79%Class III 16 17%

Why inhalers & asthma medication is recalled

Companies

Mckesson Medical-Surgical Inc. Corporate Office1011%
Integrated Health Concepts1011%
Cardinal Health99%
GlaxoSmithKline55%
Attix Pharmaceuticals44%
Cardinal Healthcare44%
Cipla USA44%
Boehringer Ingelheim Roxane33%

Brands

Albuterol Sulfate1112%
Montelukast Sodium66%
Spiriva55%
Budesonide44%
Ipratropium Bromide And Albuterol Sulfate44%
Ventolin44%
Levalbuterol Tartrate Hfa Inhalation22%
Pulmicort Respules22%

By year

202622%
202533%
202499%
20231112%
20221213%
202199%
202022%
20191314%
201844%
201766%

Ongoing inhalers & asthma medication recalls

13 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Budesonide Inhalation Suspension, 1mg recalledBudesonide	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
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
30 Jul 2025Drug	CLASS II	Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide	Cipla USA	Sterility	Nationwide
28 May 2025Drug	CLASS II	Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra	AsttraZeneca Pharmaceuticals	Packaging Defects	Nationwide
7 Feb 2024Drug	CLASS II	Budesonide Extended-Release Tablets 9mg recalledBudesonide	Teva Pharmaceuticals USA	Potency & Assay	Nationwide

All inhalers & asthma medication recalls, newest first

95 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Budesonide Inhalation Suspension, 1mg recalledBudesonide	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
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
30 Jul 2025Drug	CLASS II	Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide	Cipla USA	Sterility	Nationwide
28 May 2025Drug	CLASS II	Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra	AsttraZeneca Pharmaceuticals	Packaging Defects	Nationwide
10 Jul 2024Drug	CLASS II	Budesonide, USP (Micronized), 500 mg recalled by Medisca	Medisca	Particulate Matter	Nationwide
1 May 2024Drug	CLASS II	Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate	Cipla USA	Packaging Defects	Nationwide
7 Feb 2024Drug	CLASS II	Budesonide Extended-Release Tablets 9mg recalledBudesonide	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Budesonide Extended-Release Tablets, 9 mg recalled	Golden State Medical Supply	Potency & Assay	IL
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
3 Jan 2024Drug	CLASS II	Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Jan 2024Drug	CLASS III	Anoro Ellipta (umeclidinium recalled by GlaxoSmithKlineAnoro Ellipta	GlaxoSmithKline	Potency & Assay	Nationwide
3 Jan 2024Drug	CLASS II	Spiriva Handihaler (tiotropium bromide inhalation powder) recalledSpiriva	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
15 Nov 2023Drug	CLASS II	Montelukast Sodium Tablets, USP 10 mg recalledMontelukast Sodium	Dr. Reddy's Laboratories	Other	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
7 Jun 2023Drug	CLASS II	Xopenex (levalbuterol HCl) Inhalation Solution Concentrate recalled	Akorn	Potency & Assay	Nationwide
10 May 2023Drug	CLASS II	Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
3 May 2023Drug	CLASS II	CBD Metered Dose Inhaler (CBD) 5 mg Dose recalled	Wellness BioSciences	Other	Nationwide
12 Apr 2023Drug	CLASS II	Montelukast Sodium Tablets, USP, 10 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS III	Montelukast Sodium Oral Granules USP, 4 mg recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
5 Apr 2023Drug	CLASS II	Montelukast Sodium Tablets recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
1 Feb 2023Drug	CLASS II	Albuterol (PF/Sulfuric Acid/Dye Free) - tube recalled	Pharmacy Innovations	Sterility	Nationwide
5 Oct 2022Drug	CLASS II	Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide	Cipla	Sterility	Nationwide
15 Jun 2022Drug	CLASS III	Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	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 recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Inhalers & Asthma Medication?

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.

Alert me about Inhalers & Asthma Medication

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At a glance

Latest recall: 17 Jun 2026
First on record: 15 Aug 2012
Class I share: 4%
Ongoing: 13

Drug classes

Injectable & IV Drugs 4,626Pain Medication 1,518Creams, Ointments & Gels 930Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 495Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.