Cipla's Major Recall: Over 20,000 Asthma Medication Packs in the US

Cipla is recalling over 20,000 packs of asthma medication in the US due to failed stability specifications. The USFDA reported out-of-specification results for particle size distribution at the 12-month mark. The recall is classified as Class III, indicating no likely adverse health consequences.


Devdiscourse News Desk | New Delhi | Updated: 27-08-2025 16:07 IST | Created: 27-08-2025 16:07 IST
Cipla's Major Recall: Over 20,000 Asthma Medication Packs in the US
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Drug manufacturer Cipla is undertaking a significant recall of more than 20,000 asthma medication packs in the US.

The US Food and Drug Administration (USFDA) revealed that Cipla USA, part of the Mumbai-based pharmaceutical major, is recalling Ibuterol Sulfate Inhalation Aerosol due to failed stability specifications.

This Class III recall was initiated after particle size distribution inconsistencies were detected at the 12-month review, although it is not expected to pose health risks.

(With inputs from agencies.)

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