Drug Recall: Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence
Cipla USA, Inc. · July 24, 2025
Reason for Recall
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Product Description
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Distribution
U.S. Nationwide.
States Affected
NATIONWIDE
Quantity Affected
20352 packs (1x 200 MD)
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0593-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.