The US Food and Drug Administration (FDA) announced it is recommending the removal of all ranitidine products from the market effective immediately. Ranitidine is more commonly known by its brand name Zantac.1 Ranitidine is a histamine-2 blocker. It works to decrease the amount of acid made by the stomach. This can prevent and relieve heartburn associated with acid indigestion and sour stomach.2
It comes in multiple strengths and is available by prescription and over the counter (OTC).1 Prescription ranitidine is approved for multiple indications, including treatment and prevention of stomach and intestinal ulcers as well as treatment of gastroesophageal reflux disease (GERD).2
FDA investigation of NDMA
Since mid-2019 there has been an investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) found in ranitidine medications. NDMA is thought to be a human carcinogen; something that could cause cancer. Very low levels of NDMA are commonly found in foods and in water. They can be eaten and tolerated in small amounts. At these low levels, NDMA is not thought to lead to an increased risk of cancer. But at higher levels of long-term exposure, it may increase the risk of cancer in humans.1
This impurity, present in some products, has been found to increase over time and when stored at higher than room temperatures. This could potentially cause consumer exposure to higher, unacceptable levels of NDMA.1-2
FDA action against ranitidine
When the FDA became aware of independent laboratory testing that found NDMA in ranitidine, they then began their own testing. They confirmed the findings of NDMA in some ranitidine products at low levels. But the FDA did not have enough scientific evidence at the time to recommend whether or not it should remove all prescription and over-the-counter ranitidine.1
In September 2019 the FDA notified the public of the potential risks. They recommended people consider alternative OTC and prescription drug options. Laboratory testing continued. There were additional findings of low levels of NDMA present in some ranitidine products. Although it was not identified in every sample, this testing appeared to show some increases in NDMA levels.1
New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions. NDMA levels can increase significantly under certain conditions. These higher levels were found in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.1
Ranitidine product removal
The FDA has been unable to determine for how long or in what way the product might have been stored. So the agency determined that ranitidine should not be available to consumers unless its quality can be assured.1
All manufacturers of ranitidine are requested to withdraw their products from the market. The FDA is advising consumers who have these drugs at home to stop taking all forms, tablets or liquid, they may have. People are advised to dispose of leftover drugs properly and to not buy more.1
One manufacturer, Dr. Reddy’s Laboratories Ltd, is voluntarily recalling all prescription and over-the-counter (OTC) ranitidine tablets and capsules it manufactured. These are OTC drugs that may be privately labeled as store brands by chain stores like Walgreens, Walmart, CVS, Target, and Kroger.2 Sanofi is also voluntarily recalling Zantac OTC products due to possible NDMA contamination.1-2
The FDA recommends replacing ranitidine drugs with other approved OTC products for people needing continuing treatment. People taking prescription ranitidine should talk with their doctor about other available options. There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.
FDA testing has not identified the presence of NDMA in other similar drugs including:1-2
Ranitidine products will no longer be available for new or existing prescriptions or OTC use. The FDA has made this market withdrawal request as part of its responsibility to ensure that the medicines in the US are safe and effective.1-2
They have shared their testing methods including a newer, more widely available one which uses liquid chromatography-mass spectrometry. It is an accessible way for manufacturers and regulators to detect and measure NDMA levels in ranitidine.2
The FDA investigates potential health risks. The agency performs the regular review, surveillance, compliance, and pharmaceutical quality investigations across all product areas.
Because of the current COVID-19 pandemic, the FDA recommends that all ranitidine products not be returned to the store or brought to a drug take-back location. It is recommended that everyone follow the specific disposal instructions in the package insert or follow the FDA steps to safely dispose of these medications at home.1
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA News Release. Available at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market?utm_campaign=040120_PR_FDA%20Requests%20Removal%20of%20Ranitidine%20Products%20%28Zantac%29%20from%20the%20Market&utm_medium=email&utm_source=Eloqua. Accessed 4/1/20.
10/23/19: UPDATE – FDA releases additional NDMA testing method and alerts health care professionals and patients to multiple voluntary recalls of ranitidine. Available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. Accessed 4/1/20.