FDA allows reformulated ranitidine back on the market

More than five years after the US Food and Drug Administration (FDA) asked manufacturers to pull drugs with ranitidine off the shelves due to concerns of elevated cancer risk, the agency has approved a reformulated version of the drug. The agency has also asked consumers to take certain steps to reduce the risk of the drug producing carcinogens.

In April 2020, FDA asked manufacturers to remove all prescription and over-the-counter (OTC) versions of drugs containing ranitidine, commonly known as Zantac, from the market after the agency's research found that when stored at higher temperatures, it can produce the carcinogen N-Nitrosodimethylamine (NDMA). Ranitidine is an H2 receptor antagonist used to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Earlier this week, FDA said it had approved a reformulated ranitidine after extensive testing that found, among other things, that manufacturing improvements can reduce the risk of NDMA formation.

"Healthcare providers and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products," said FDA. "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," the agency added.

FDA also advised that patients and healthcare providers take steps such as discarding unused tablets from opened pill bottles after three months, ensuring the drugs are sealed in their bottles, and protecting the drugs from moisture.

The news comes after FDA announced last month that researching nitrosamine drug impurities was one of its eight generic drug research priorities for fiscal year 2026 (RELATED: FDA lists its upcoming research priorities for generic drugs, Regulatory Focus, 1 October 2025).

"This research area focuses on understanding how ingredients in drug products may either contribute to or mitigate the formation of potentially harmful impurities such as nitrosamine adducts (e.g., nitrosamine drug substance related impurities (NDSRIs)), evaluating the risk of human exposure to these impurities, and developing methods for abbreviated new drug application (ANDA) applicants to efficiently address the potential risks," said the agency in its announcement.

Over the past few years, FDA has also asked manufacturers to conduct NDSRI testing for approved drugs (RELATED: FDA’s top generic drug official urges firms to complete nitrosamine risk assessments, Regulatory Focus, 27 October 2025).

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FDA allows reformulated ranitidine back on the market

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