Reported Jun 17, 2026 · Ongoing
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49
- Lot codes and dates
- Lot #: BAG0074A, Exp
- Date1/31/2027
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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