FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review

New Formulation Addresses Previous NDMA Impurity Formation Concerns [11/24/2025] Today, the U.S. Food and Drug Administration approved reformulated ranitidine tablets, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life. Ranitidine, an H2 receptor antagonist, is widely used to treat conditions including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Clinical Considerations: Healthcare providers and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products. Patients currently using alternative H2 blockers or proton pump inhibitors should consult their healthcare providers before switching medications. Approved products will include updated labeling with storage and handling instructions. Patients and healthcare providers should consider the new storage conditions for the safe and effective use of the product which include: