Drug recall D-0607-2026
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 for recall
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
Lots and codes
Lot #: BAG0074A, Exp. Date: 1/31/2027.
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- N/A
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 29, 2026
Related products
- Budesonide – drug information
- NDC 47335-633 Budesonide · Budesonide 1 mg/2mL · Sun Pharmaceutical Industries, Inc.
- NDC 47335-632 Budesonide · Budesonide .5 mg/2mL · Sun Pharmaceutical Industries, Inc.
- NDC 47335-631 Budesonide · Budesonide .25 mg/2mL · Sun Pharmaceutical Industries, Inc.