Cipla USA, Inc. recalls Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, I
Recalled August 27, 2025 · FDA recall D-0593-2025 · Cipla USA
Hazard
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. · FDA Class III
Units
20352 packs (1x 200 MD)
Sold at
U.S. Nationwide.
Description
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
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.
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →