FDA Recalls All Ranitidine (Zantac) Products, Citing Increased Risk of Cancer

The FDA has requested all ranitidine (Zantac) products be pulled from the market immediately, according to a statement. The recall includes all prescription and over-the-counter ranitidine drugs as ongoing investigations uncovered levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, increase over time.

“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA stated.

Consumers are advised to stop taking any ranitidine medications they may have, as the drug is commonly indicated for heartburn. The FDA learned an independent laboratory found NDMA in ranitidine in the summer of 2019. When the FDA conducted its own testing, it found NDMA in low levels, which “would not be expected to lead to an increase in risk in cancer.”

At that time, the FDA “did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines and continued its investigation.” However, the agency notes it “warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.”

Subsequent testing found NDMA increased in ranitidine “even under normal storage conditions,” yet increases significantly in higher than normal temperatures. These tests also found that the older a ranitidine product is, the greater the level of NDMA. While low levels of NDMA are not harmful to humans, sustained higher levels may increase the risk of cancer.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”

Due to the COVID-19 pandemic, the FDA notes consumers should not dispose of the medication at a drug take-back location, but instead follow specific disposal instructions.

If any patients took ranitidine-containing medication and experienced adverse reactions, they should report it though the agency’s MedWatch reporting program.

The agency urges patients and providers to consider taking alternative medications. “To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec)."