Reported Aug 27, 2025 · Ongoing

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd,…

Cipla USA, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730

Is this the product you have?

    • Albuterol Sulfate
    • Inhalation Aerosol
    • 90 mcg
    • 200 metered Inhalations
    • NET CONTENT 6.7 g
  • Manufactured byCipla Ltd, Indore, SEZ, Pithampur, India
  • Manufactured for
    • Cipla USA
    • Inc. 10 Independence Boulevard
    • Suite 300
    • Warren
    • NJ 07059
    • NDC 69097-142-60
Lot codes and dates
    • Lot#: 4IB0519
    • Exp. 04/30/2026
Amount recalled
20352 packs (1x 200 MD)

Where it was sold

  • Nationwide

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.