Budesonide recalls

The FDA has published 9 recalls involving Budesonide since 2013. The latest was reported on 17 Jun 2026. Most were for potency & assay. AstraZeneca 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 recalls9since 2013

Last 12 months1reported

Class I00% of total

Ongoing3latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 1Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 1 0Jul 0 0

Severity split

Class I 0 0%Class II 6 67%Class III 3 33%

Why budesonide is recalled

Companies

AstraZeneca222%
Cardinal Health111%
CIPLA111%
Teva Pharmaceuticals USA111%
Golden State Medical Supply111%
Cipla USA111%
Sun Pharmaceutical Industries111%
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)111%

Brands

Budesonide444%
Pulmicort Respules222%
Budesonide And Formoterol Fumarate Dihydrate111%

By year

2026111%
2025111%
2024222%
2022111%
2021111%
2013333%

Ongoing budesonide recalls

3 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, 5mg/-dose ampules per, five recalledBudesonide	Cipla USA	Sterility	Nationwide
7 Feb 2024Drug	CLASS II	Budesonide Extended-Release Tablets 9mg recalledBudesonide	Teva Pharmaceuticals USA	Potency & Assay	Nationwide

All budesonide recalls, newest first

9 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, 5mg/-dose ampules per, five recalledBudesonide	Cipla USA	Sterility	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
5 Oct 2022Drug	CLASS II	Budesonide Inhalation Suspension 25mg/, For Inhalation Only recalledBudesonide	CIPLA	Sterility	Nationwide
2 Jun 2021Drug	CLASS II	Budesonide and Formoterol Fumarate Dihydrate Inhalation recalledBudesonide And Formoterol Fumarate Dihydrate	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
29 May 2013Drug	CLASS III	Budesonide Capsules, 3 mg, Enteric Coated recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
20 Mar 2013Drug	CLASS III	Pulmicort Respules 25 mg/ Budesonide Inhalation Suspension recalledPulmicort Respules	AstraZeneca	Other	Nationwide
20 Mar 2013Drug	CLASS III	Pulmicort Respules 5 mg/ (30 ampules/carton) Budesonide recalledPulmicort Respules	AstraZeneca	Other	Nationwide

Should you stop taking Budesonide?

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.