Sun Pharmaceutical Industries Inc: Budesonide Inhalation Suspension, 1mg/2ml, 30 X

Recall Summary Sun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) distributed nationwide because black or brown particles and specs were found in some ampules. This medication is used to treat breathing problems and is distributed in single-dose ampules across all U.S. states.

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC

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.

Reason

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-05-29

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/e2059bde-3f9f-4954-a0f9-a343e273942d