Cipla USA, Inc.: Drug Recall

Recall #D-0593-2025 · 07/24/2025

Class III: Low Risk

Recall Details

Recall Number
D-0593-2025
Classification
Class III
Product Type
Drug
Recalling Firm
Cipla USA, Inc.
Status
Ongoing
Date Initiated
07/24/2025
Location
Warren, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20352 packs (1x 200 MD)

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 Pattern

U.S. Nationwide.

Other Recalls by Cipla USA, Inc.

View all recalls by Cipla USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.