Recall: D-0593-2025

Class III - Minor Violations

Class IIIClassification

2025-07-24Initiated

OngoingStatus

Cipla USA, Inc.Firm

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.

Reason

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.

Distribution

U.S. Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.