Is Zantac, specifically the brand-name medication previously marketed as an over-the-counter and prescription drug for heartburn and acid reflux, currently legally available for sale in the United States? I’m aware of past recalls and concerns regarding NDMA contamination. Is brand-name Zantac, manufactured and sold by Sanofi or its authorized distributors, now available, and if so, under what conditions (e.g., prescription only, specific formulation)? If not available as Zantac, are there currently approved generic versions of ranitidine being sold in the US, and if so, are they subject to the same NDMA concerns? What is the official FDA position on the safety and availability of ranitidine-based medications now?

Answer

As of 2024, Zantac (ranitidine) is not currently available for sale in the US with its original formulation.

Background:
Ranitidine, the active ingredient in Zantac, was a widely used heartburn medication. In 2019, the FDA announced that some ranitidine products were found to contain N-Nitrosodimethylamine (NDMA), a probable human carcinogen. This led to recalls of ranitidine products, including Zantac.

Regulatory Actions:
In April 2020, the FDA requested manufacturers to withdraw all prescription and over-the-counter ranitidine products from the market. The FDA determined that the risk to public health was sufficient to warrant removing these products.

Current Status:
While the original Zantac formulation is not available, some reformulated versions of Zantac that contain different active ingredients such as famotidine are available.