SUN PHARMACEUTICAL INDUSTRIES INC recalls Budesonide Inhalation Suspension
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- May 29, 2026
- Reported
- Jun 17, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot #: BAG0074A, Exp. Date: 1/31/2027.
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0607-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0607-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.