Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Budesonide Inhalation Suspension 0.25mg/2mL Recalled by CIPLA Due to Lack of Assurance of Sterility
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 directly.
Affected Products
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Quantity: 641,160 ampules
Why Was This Recalled?
Lack of Assurance of Sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CIPLA
CIPLA has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report