Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Budesonide Inhalation Suspension Recalled by Cipla USA, Inc. Due to Lack of Assurance of Sterility: A market complaint...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cipla USA, Inc. directly.
Affected Products
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)
Quantity: 13,680 ampoules
Why Was This Recalled?
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cipla USA, Inc.
Cipla USA, Inc. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report