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 specks and particles have been found in some ampules. This medication is used to treat asthma and other respiratory conditions. The recall affects product with NDC 47335-633-49 that was distributed 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
- 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/f81e61fc-a62b-4cc2-99a8-ea424ae49379