Asthma and inhaler recalls
17 FDA-recorded recalls of asthma and inhalers, most recent May 2026 — newest first, straight from the FDA's own database.
Inhaler recalls are as often about the DEVICE as the medicine — defective containers are the leading reason in our data, and a canister that does not deliver its dose is a rescue inhaler that fails at the moment it is needed. That is why an inhaler recall should never be handled by simply not using it: if your lot is named, get a replacement before you need it, and keep the old one until the new one is in your hand.
Budesonide Inhalation Suspension
Class IIPresence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
SUN PHARMACEUTICAL INDUSTRIES INC · Jun 17, 2026
Albuterol Sulfate Inhalation Solution
Class IILabelling: Illegible label
Nephron SC, LLC · Apr 22, 2026
Theophylline extended-release tablets 400mg
Class IIFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Glenmark Pharmaceuticals Inc., USA · Aug 20, 2025
Albuterol Sulfate
Class IIIFailed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Cipla USA, Inc. · Aug 27, 2025
Budesonide Inhalation Suspension
Class IILack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Cipla USA, Inc. · Jul 30, 2025
Theophylline (Anhydrous) Extended-Release Tablets
Class IIOOS results reported for the Dissolution (by UV) test.
Glenmark Pharmaceuticals Inc., USA · Jun 4, 2025
Airsupra (albuterol and budesonide) inhalation aerosol
Class IIDefective delivery system
AsttraZeneca Pharmaceuticals LP · May 28, 2025
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray
Class IIDefective Delivery System: The dip tube is clogged causing the spray not to work.
Glenmark Pharmaceuticals Inc., USA · Oct 9, 2024
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p…
Class IICGMP Deviations and Presence of Particulate Matter: Glass
Medisca Inc. · Jul 10, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · Jun 19, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · Jun 19, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · Jun 19, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Class IIShort fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Cipla USA, Inc. · May 1, 2024
Fluticasone Propionate Nasal Spray USP
Class IICGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Golden State Medical Supply Inc. · Mar 6, 2024
Fluticasone Propionate Nasal Spray USP 50mcg
Class IICGMP Deviations: potential presence of Burkholderia cepacia complex
Apotex Corp. · Feb 28, 2024
Budesonide Extended-Release Tablets
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Feb 7, 2024
Budesonide Extended-Release Tablets 9mg
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Feb 7, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antidepressant · Antibiotic · Thyroid medication · Allergy and antihistamine · Hormonal and contraceptive · ADHD and stimulant medication · Opioid and pain medication · Seizure and epilepsy medication · Heartburn and acid-reflux medication. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.