FDA Recalls – Zantac

Timeline of Zantac

Zantac® is sold prescription and non-prescription versions.  It was once touted as the best-selling drug in history.  That changed when Valisure, a small pharmacy based in New Haven, Connecticut linked “Zantac® and its generics to the carcinogen [N-nitrosodimethylamine (NDMA)] during its routine testing…”

June 2019:

Valisure first notified the U.S. Food and Drug Administration (FDA) of the NDMA contamination present in Zantac® in June 2019.

September 9, 2019:

On September 9th, 2019 Valisure petitioned the FDA and requested a recall and the suspension of sales of ranitidine from the U.S. market.   “Valisure filed a detailed petition with the Food and Drug Administration asking the agency to recall all products containing ranitidine. Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule.”  Valisure reported to the FDA levels as high as 3 million nanograms per tablet and went on to explain that, “[e]ven if the manufacturing has produced a clean product, that can’t guarantee that it remains free of NDMA.”  In plain language, all manufacturers, brand or generic, and all lots of ranitidine-containing medications “are affected and could generate very high levels of NDMA in the human body.”

September 13, 2019:

On September 13, 2019, the FDA revealed that the widely used heartburn medication known as Zantac® contains levels of a cancer-causing contaminant known as NDMA.  NDMA was previously identified in a blood pressure drug, leading to recalls.

The FDA’s investigation raised significant concerns about the risk of cancers of the liver, stomach, bladder, kidney, and other organs, especially for those who regularly used the drug.

September 23, 2019:

Sandoz Inc. issues voluntary recall of Ranitidine Hydrochloride Capsules 150mg and 300mg because of an high amount of NDMA in the Product.

November 1, 2019:

Initially, the FDA downplayed the risks caused by contamination of the already recalled heartburn drug Zantac®, saying “its tests suggest it does not cause carcinogens to form after ingestion by patients.”

Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, further downplayed the risks and said in a statement that the levels of the probable carcinogen NDMA it found in Zantac® “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

The FDA’s results of its testing on Zantac® (and some versions of its generic over-the-counter counterparts) had nine times the FDA “acceptable limit” for NDMA.

Valisure CEO, David Light, in a statement criticized FDA testing methods as “overly simplistic” and urged the agency to completely recall ranitidine and a similar drug, nizatidine.

October 18, 2019:

At first, Sanofi, the manufacturer of Zantac®, did not issue a recall even when other companies did.  The company told the New York Times that preliminary NDMA levels in the medicine “barely exceed amounts found in common foods.”

Approximately 4 months after the FDA was first alerted to the presence of NDMA in Zantac, Sanofi said it was issuing a voluntary recall of the over-the-counter formula of Zantac® that was distributed in the United States and Canada.

March 27, 2020:

By March 27, 2020, a total of 15 companies had issued ranitidine recalls in the United States.

APRIL 1, 2020:

The U.S. Food and Drug Administration (“FDA”) requested that all Ranitidine products (e.g. Zantac®) be removed from the market.   However, some companies voluntarily recalled the medication prior to the April 1st order:

• Several companies voluntarily recalled Zantac® a few months after the FDA detected the cancer-causing chemical NDMA in several brand name and generic heartburn medications and opened an investigation.
• After the FDA’s formal investigation began, Sanofi announced on their website that “[D]ue to inconsistencies in preliminary test results of the active ingredient used in Zantac® products, Sanofi has made the decision to conduct a voluntary recall in the U.S. and Canada as the investigation continues.” The website still has a “Buy Now” option.

The FDA ultimately stepped in and issued the recall because it “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 also advised “consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.”