Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, I
Summary
The FDA issued a Class III for Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONT by Cipla USA, Inc.. Reason: Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the .
Details
Source
Drug Recall
External ID
D-0593-2025
Action Date
2025-08-27
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot#: 4IB0519, Exp. 04/30/2026
Quantity Affected: 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.
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-24
Company
Warren, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla USA, Inc. have FDA actions?
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0593-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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