Recalls / Class II
Class IID-0541-2025
Product
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)
- Brand name
- Budesonide
- Generic name
- Budesonide
- Active ingredient
- Budesonide
- Route
- Oral
- NDCs
- 69097-318, 69097-319, 69097-321
- FDA application
- ANDA205710
- Affected lot / code info
- Batch # 4IA0505, Exp 09/31/2026
Why it was recalled
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 13,680 ampoules
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-06-30
- FDA classified
- 2025-07-22
- Posted by FDA
- 2025-07-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0541-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.