Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by
Recalled July 30, 2025 · FDA recall D-0541-2025 · Cipla USA
Hazard
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. · FDA Class II
Units
13,680 ampoules
Sold at
Distributed Nationwide in the USA
Description
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
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)
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →