Budesonide Inhalation Suspension
Sun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) due to the presence of foreign black or brown particles.
Examine your medication for any visible particles or discoloration. If found, do not use the product and contact your healthcare provider or pharmacist for a replacement or further instructions.
Why it was recalled
Sun Pharmaceutical is recalling Budesonide Inhalation Suspension due to the presence of foreign black or brown particulate matter within the ampoule solution. This recall affects the 1mg/2mL strength, packaged as 30 x 2 mL sterile single-dose ampules.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0607-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Editorial summary by Recall Canary · last updated 2026-06-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification