Cipla USA, Inc. recalled 20,352 packs of Albuterol Sulfate inhalation aerosol on July 24, 2025. The recall follows out-of-specification results in particle size distribution during stability testing. Consumers must stop using the product immediately.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
The recall involves Albuterol Sulfate inhalation aerosol, 90 mcg, 200 metered inhalations per pack. The affected lot number is 4IB0519, with an expiration date of April 30, 2026. The product was distributed nationwide in the U.S.
This product failed stability specifications, which may affect its efficacy. Out-of-specification results were observed during analysis of particle size distribution at the 12-month time point.
No specific incidents of injury or adverse effects have been reported. The recall is precautionary due to stability concerns.
Stop using the product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance on further action.
For more information, consumers can visit the FDA website or contact Cipla USA, Inc. at their customer service number.
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