Cipla USA, Inc. recalls Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd,…

Recall date

July 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0593-2025

FDA classification

Class III

Brand / firm

Cipla USA, Inc.

Sold / distributed

U.S. Nationwide.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.