FDA Issues Class II Recall for Azelaic Acid Gel 15% Due to Gritty Texture

The US Food and Drug Administration (FDA) has issued a Class II recall for Azelaic Acid Gel, 15% (50 grams) manufactured by Glenmark Pharmaceuticals Limited in Goa, India, and distributed by Glenmark Pharmaceuticals Inc., USA, based in Mahwah, New Jersey. The recall affects 13 824 tubes from Batch #19252524, with an expiration date of May 2027. The recall was prompted by consumer complaints of a gritty or grainy texture, indicating a deviation from expected product quality. The voluntary recall was initiated on September 17, 2025, and applies to product distributed nationwide within the United States.

The FDA classified the recall as Class II on September 24, 2025, signifying that use of the affected product may cause temporary or medically reversible adverse health effects, with a low probability of serious harm. Although no contamination or safety issues were confirmed, the unexpected texture variation may impact patient comfort, compliance, and therapeutic experience. 

Azelaic acid gel is a topical treatment indicated for mild to moderate inflammatory acne vulgaris and rosacea. It works by reducing inflammation and bacterial growth on the skin. While the gritty texture is not expected to affect drug potency or safety, it may deter patients from using the product as prescribed. Pharmacists should check their inventory for NDC 68462-626-52, isolate affected lots, and advise prescribers or patients to request alternative batches or comparable treatments if the texture proves bothersome. 

Reference
FDA. Enforcement Report. October 1, 2025. Accessed October 1, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=216121