Budesonide recalls

Budesonide products have been recalled 3 times, most recently on 17 Jun 2026. The recalling company is usually SUN Pharmaceutical Industries. The most common reason is sterility.

Total recalls3since 2022

Last 12 months1reported

Class I00% of total

Ongoing2latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why budesonide is recalled

Sterility267%
Particulate Matter133%

Companies

Product types

Inhalers & Asthma Medication3100%

By year

2026133%
2025133%
2022133%

Ongoing budesonide recalls

2 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Budesonide Inhalation Suspension, 1mg recalledBudesonide	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
30 Jul 2025Drug	CLASS II	Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide	Cipla USA	Sterility	Nationwide

All budesonide recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Budesonide Inhalation Suspension, 1mg recalledBudesonide	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
30 Jul 2025Drug	CLASS II	Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide	Cipla USA	Sterility	Nationwide
5 Oct 2022Drug	CLASS II	Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide	Cipla	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.