FDAHealthMay 29, 2026
SUN PHARMACEUTICAL INDUSTRIES INC — 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 Pharmac
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 29, 2026
Nationwide within the United States
What's affected?
- 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.
- Brand
- BUDESONIDE
- Lot code
- BAG0074A
Additional details
Lot #: BAG0074A, Exp. Date: 1/31/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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