Budesonide Inhalation Suspension, 1mg/2mL
Recalled by SUN PHARMACEUTICAL INDUSTRIES INC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
SUN PHARMACEUTICAL INDUSTRIES INC has recalled Budesonide Inhalation Suspension, 1mg/2mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 17, 2026 and was initiated on May 29, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Budesonide Inhalation Suspension, 1mg/2mL, with approximately N/A affected. The company behind the recall is SUN PHARMACEUTICAL INDUSTRIES INC, based in Princeton, NJ. The FDA describes the product as: “Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Li…”
Why was Budesonide Inhalation Suspension, 1mg/2mL recalled?
According to the FDA, the stated reason for the recall is: “Presence 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.”
What should you do?
If you think you may have bought Budesonide Inhalation Suspension, 1mg/2mL, compare it against the product description and identifying codes (Lot #: BAG0074A, Exp. Date: 1/31/2027.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact SUN PHARMACEUTICAL INDUSTRIES INC or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- June 17, 2026
- Recall started
- May 29, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Budesonide Inhalation Suspension, 1mg/2mL recalled?+
According to the FDA: Presence of Foreign Substance:This recall has been initiated in response to a product quality com…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Budesonide Inhalation Suspension, 1mg/2mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0607-2026. Information last synced from the FDA on July 5, 2026.