Glenmark Pharmaceuticals’ US-based subsidiary -- Glenmark Pharmaceuticals Inc, USA is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to ‘CGMP deviations’ following market complaints received for gritty texture. Glenmark Pharmaceuticals Inc has initiated the Class II nationwide recall on September 17, 2025.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Glenmark Pharmaceuticals (Glenmark) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
