FDA-Drug2026-06-17Class IIPROCESSING DEFECT
Sun Pharmaceutical budesonide inhalation suspension recalled for foreign particles
Nationwide distribution
Sun Pharmaceutical budesonide recalled for foreign particles
Sun Pharmaceutical has recalled budesonide inhalation suspension (1mg/2mL single-dose ampules) due to the presence of black or brown specs and particles found in some vials. The affected lot is BAG0074A with an expiration date of January 31, 2027. This is a quality issue that could affect the safety and sterility of the medication.
- Check your budesonide ampules for lot number BAG0074A (expiration 1/31/2027)
- Do not use ampules from this lot if you see any discoloration, specs, or particles in the solution
- Contact your pharmacy or healthcare provider if you have this lot
Hazard
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
Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0607-2026More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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