FDAFDA · Food and drugs·Recall number D-0607-2026
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.
Published June 17, 2026 · Recall initiated: May 29, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUDESONIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: BAG0074A, Exp. Date: 1/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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