Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.
CGMP Deviations: Market complaints received for gritty texture (grainy)
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Azelaic Acid Gel, 15%, in 50-gram tubes. It is manufactured by Glenmark Pharmaceuticals Limited in Goa, India, for Glenmark Pharmaceuticals Inc. in Mahwah, New Jersey. The affected batch number is 19252524, with an expiration date of May 2027.
The recall is due to CGMP deviations linked to a gritty texture reported by users. This issue does not pose a direct health hazard but may affect the product's effectiveness and user experience.
There are no reported injuries or adverse health effects associated with this recall. Complaints focus solely on the product's texture.
Consumers should stop using Azelaic Acid Gel immediately. Contact Glenmark Pharmaceuticals Inc. or your healthcare provider for further guidance and possible return options.
For more information, call Glenmark Pharmaceuticals Inc. at their customer service number or visit their website. The recall information is also available on the FDA's website.
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