Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIDrug recallOngoing

Budesonide Inhalation Suspension recall

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC of Princeton, NJ · FDA report 06/17/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Ongoing
Recall started: 05/29/2026
Distribution: Nationwide

Reason for recall

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

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product: 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 Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Lot and code info: Lot #: BAG0074A, Exp. Date: 1/31/2027.
Brand names: BUDESONIDE
Recall number: D-0607-2026
Event ID: 99113
Initiated by: Voluntary: Firm initiated

Where it was distributed

Nationwide within the United States

Nationwide

Recall timeline

05/29/2026Firm started the recall
06/17/2026Published in the FDA enforcement report
06/18/2026FDA classified it as Class II

More recalls from SUN PHARMACEUTICAL INDUSTRIES

Frequently asked questions

Why was Budesonide Inhalation Suspension recalled?: 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 does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: Nationwide within the United States
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 06/17/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Ongoing
Type: Drug
Reported: 06/17/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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