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)
Reported: July 30, 2025 Initiated: June 30, 2025 #D-0541-2025
Product Description
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)
Reason for Recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Details
- Recalling Firm
- Cipla USA, Inc.
- Units Affected
- 13,680 ampoules
- Distribution
- Distributed Nationwide in the USA
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Cipla USA, Inc.. Units affected: 13,680 ampoules.
Why was this product recalled? ▼
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2025. Severity: Moderate. Recall number: D-0541-2025.
Related Recalls
NHTSA Critical
LEXUS 2025: POWER TRAIN:AUTOMATIC TRANSMISSION
LEXUS · 2026-02-18
NHTSA Critical
CADILLAC,CHEVROLET,GMC 2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CADILLAC,CHEVROLET,GMC · 2026-02-13
NHTSA Critical
CHEVROLET,GMC 2020-2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CHEVROLET,GMC · 2026-02-12
NHTSA Critical
CADILLAC 2024: BACK OVER PREVENTION:SOFTWARE
CADILLAC · 2026-02-12
NHTSA Critical
NISSAN 2024-2025: FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM:THROTTLEBODY/MANIFOLD
NISSAN · 2026-02-12