Budesonide Inhalation Suspension recalled over sterility concerns
- Recall date
- June 30, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured b…
- Recall number
- D-0541-2025
- FDA classification
- Class II
- Brand / firm
- Cipla USA, Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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)
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