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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

Cipla USA, Inc. 2025-08-27 Health moderate FDA
Health · FDA · Recall #FDA-D-0593-2025

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7… Recall

Issued August 27, 2025 · Cipla USA, Inc.

In August 2025, Cipla USA, Inc. recalled the Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Cipla USA, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Cipla USA, Inc.
Category
Health
Recall date
August 27, 2025
Units affected
Not reported
Sold at
U.S. Nationwide.
Recall number
FDA-D-0593-2025
Made in
United States
Issuing agency
FDA

In context

  • Cipla USA, Inc. has 9 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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