ALBUTEROL SULFATE
Recalling Firm / Manufacturer: Cipla USA, Inc.
(Warren, NJ, United States)
FDA Recall Number: D-0593-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ALBUTEROL SULFATE
Generic Name
ALBUTEROL SULFATE
Active Substance(s)
Albuterol Sulfate
Administration Route
Respiratory (inhalation)
National Drug Code (NDC)
69097-142
Total Quantity Recalled
20352 packs (1x 200 MD)
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
August 27, 2025
Firm Initiation Date
July 24, 2025
FDA Classification Date
Aug 20, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot#: 4IB0519, Exp. 04/30/2026
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0593-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC