FDAFDA · Food and drugs·Recall number D-0541-2025
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Published July 30, 2025 · Recall initiated: June 30, 2025
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
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUDESONIDE
- Manufacturer
- Cipla USA, Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Batch # 4IA0505, Exp 09/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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