The FDA requested that Zantac (ranitidine) be withdrawn from the market in April 2020. Manufacturers issued a recall of all ranitidine Zantac products because the drugs may contain N-Nitrosodimethylamine (NDMA), a cancer-causing chemical.
Sandoz was the first company to issue a voluntary generic Zantac recall on Sept. 24, 2019. Other generic manufacturers soon followed, including brand name Zantac drug maker Sanofi.
Manufacturers are no longer selling brand name or generic Zantac with ranitidine in the United States.
In addition to the U.S., dozens of other countries and jurisdictions have responded to the news of contamination by issuing bans, recalls or warnings.
What to Know About the Zantac Recall
Zantac recalls from individual companies started in September 2019. The FDA issued the April 2020 market withdrawal because it found that levels of NDMA in ranitidine increase over time when the drug is stored under normal conditions. These levels increase significantly when stored at higher temperatures.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. 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.”
Normally, low levels of NDMA do not affect people, but higher levels could increase the risk of cancer. It’s important to note that taking ranitidine might increase your cancer risk, but it doesn’t mean you will get cancer.
These Zantac recalls don’t affect Sanofi’s OTC formula of Zantac360 that contains famotidine. FDA tests have not found NDMA in famotidine.
FDA Ranitidine Recall Timeline
The events leading up to the Zantac recall started on Sept. 9, 2019, when the online pharmacy Valisure told the FDA it found NDMA in samples of generic and brand name Zantac.
After the FDA conducted more testing, the agency issued a request for all manufacturers to withdraw all ranitidine products from the market because of NDMA dangers.
September 9, 2019
Valisure discovers NDMA in every lot of ranitidine it tested and petitions the FDA to recall and suspend sales of ranitidine from the U.S. market. The pharmacy found levels in excess of 3,000,000 nanograms. The acceptable daily limit is 96 nanograms.
September 13, 2019
The FDA’s Director for Drug Evaluation and Research, Dr. Janet Woodcock, issues a statement that some ranitidine medicines may contain NDMA. The FDA releases a method called Liquid Chromatography-High Resolution Mass Spectrometry, or LC-HRMS, for determining the presence of NDMA in ranitidine. The FDA recommends that manufacturers test their products and send samples to the FDA for further testing.
September 24, 2019
The FDA announces the first recall. Sandoz issues a voluntary recall for 14 lots of prescription ranitidine capsules after it found NDMA in the medicines.
September 28 to October 2, 2019
Walgreens, CVS Pharmacy, Rite-Aid and Walmart suspend all sales of brand-name Zantac and its generics.
October 17, 2019
The FDA releases a second method for detecting NDMA in ranitidine, Liquid Chromatography-Tandem Mass Spectrometry, or LC-MS/MS.
October 18, 2019
Sanofi issues a recall for over-the-counter brand-name Zantac 150, 150 Cool Mint and Zantac 75. This is the first brand-name recall.
November 1, 2019
The FDA releases results of its NDMA testing. Levels of NDMA range from 0.03 to 2.85 parts per million, or ppm, in 18 different products. The FDA says these levels are consistent with levels in common foods like grilled or smoked meats.
December 4, 2019
The FDA advises manufacturers to test all lots of ranitidine-containing products. Manufacturers should not sell products that contain NDMA levels above the acceptable daily intake and should inform the FDA.
January 6, 2020
Denton Pharma Inc. dba Northwind Pharmaceuticals becomes the 14th generic Zantac manufacturer to issue a recall in the United States.
February 27, 2020
American Health Packaging added a recall for ranitidine tablets manufactured by Amneal.
April 1, 2020
The FDA announced an immediate market withdrawal request for all prescription and over-the-counter ranitidine drugs.
Manufacturers Involved in the Zantac Recall
As of April 2020, all Zantac manufacturers have withdrawn their ranitidine products from the market, including generics and store brands.
For more details on lot numbers for companies that announced recalls, please check the FDA’s ranitidine recall updates and press announcements page. You can also check with your local pharmacist.
- In October 2019, Sanofi issued a recall for over-the-counter brand-name Zantac 150, 150 Cool Mint and Zantac 75.
- The Sandoz recall issued on Sept. 23, 2019, affects 150 mg and 300 mg doses of ranitidine in 20, 60 and 500 count bottles.
- Apotex supplies generic ranitidine to Walgreens, Walmart and Rite Aid. The company issued a precautionary recall on Sept. 25, 2019. Its recall affects store brands of ranitidine 75 mg and 150 mg tablets.
- Perrigo Company PLC
- Perrigo issued a voluntary worldwide recall for all lots and pack sizes of its ranitidine medications at the retail customer level. Before it announced the recall, the company halted shipments on Oct. 8, 2019.
- Dr. Reddy’s Laboratories Ltd.
- On Oct. 1, 2019, Dr. Reddy’s Laboratories issued a recall for its prescription and OTC ranitidine products, available from several retailers including Target, Sam’s Club, Walmart, CVS and Walgreens.
- Lannett Company Inc.
- Lannett Company began testing the active pharmaceutical ingredient, or API, in its ranitidine syrup products on Sept. 17, 2019. The test confirmed the presence of NDMA.
- Novitium Pharma LLC
- Novitium Pharma announced its voluntary recall of all quantities and lots of ranitidine products on Oct. 25, 2019.
- Aurobindo Pharma USA
- On Nov. 6, 2019, Aurobindo recalled 1 lot of ranitidine 150 mg tablets at the retail level and 37 lots of 150 mg capsules, 300 mg capsules and 15 mg/mL of ranitidine syrup. The company said it detected NDMA in the products.
- American Health Packaging
- On Nov. 8, 2019, American Health Packaging, also called AHP, issued a voluntary recall for its 150 mg/10 mL ranitidine syrup. The company said it detected trace amounts of NDMA. On February 27, 2020, AHP added a recall of 11 lots of ranitidine tablets that were manufactured by Amneal Pharmaceuticals and repackaged by AHP.
- Golden State Medical Supply Inc.
- GSMS, Inc. received a notification from Novitium on Oct. 25, 2019, and initiated a recall on Nov. 6, 2019. The recall affects 7 lots of its ranitidine HCl 150 mg capsules and 12 lots of ranitidine HCl 300 mg capsules. The recalled lots were sold to AmerisourceBergen, McKesson and Tricare Mail Order Pharmacies.
- Precision Dose Inc.
- Drug repackager Precision Dose Inc. issued a voluntary recall for 5 lots of ranitidine oral solution 150 mg/10 mL. The company issued the recall in response to a recall by Amneal Pharmaceuticals LLC.
- Amneal Pharmaceuticals LLC
- Amneal issued its ranitidine recall on Nov. 8, 2019, because of potential NDMA amounts above the FDA’s established acceptable levels. Ranitidine tablets, 150 mg and 300 mg, and ranitidine syrup 15 mg/mL.
- Glenmark Pharmaceuticals Inc.
- Glenmark recalled 928 unexpired lots of ranitidine 150 mg and 300 mg tablets on Dec. 17, 2019. The company said the lots contain or may contain NDMA above the FDA’s acceptable levels.
- Denton Pharma dba Northwind Pharmaceuticals
- On Jan. 6, 2020, Northwind Pharmaceuticals announced its recall of ranitidine 150 mg and 300 mg tablets. Denton Pharma repackaged these lots and distributed them to Northwind Pharmaceuticals LLC and Crosswind Pharmacy.
- Appco Pharma LLC
- On Jan. 7, 2020, Appco recalled 8 lots of its ranitidine 150 mg and 300 mg capsules. Appco’s marketing partner, ANI Pharmaceuticals Inc., was in charge of notifying distributors and customers.
How Dangerous Is NDMA?
Food and water have some levels of NDMA, but typically the levels are not enough to cause harm. However, according to Valisure’s data, a single tablet of Zantac may contain amounts of NDMA several thousand times more than is safe.
Ranitidine is not the first drug to be recalled because of NDMA contamination. In July 2018, the FDA announced valsartan recalls because several batches of the drug contained NDMA.
According to the Environmental Protection Agency, animals exposed to the chemical have developed tumors in the liver, blood vessels, kidneys and respiratory tract.
NDMA is a “probable human carcinogen.” This means it is a potent carcinogen in animals, but there aren’t enough studies to verify its carcinogenic effect on humans.
Zantac Recall Leads to Lawsuits
The Zantac recalls and market withdrawal have led thousands of people to file Zantac lawsuits against manufacturers including Pfizer, Sanofi and Boehringer Ingelheim.
Lawsuits claimed that Zantac caused various types of cancer in people who used the drug. Bladder cancer was the main type of cancer being accepted in these cases. Cases claimed drugmakers knew about Zantac’s cancer risks but did not warn the public and that ranitidine has design defects.
As of Dec. 15, 2022, there were over 2,000 lawsuits pending in federal court in Florida and hundreds more in state courts. Joseph Baker’s case was the first scheduled to go to trial in Illinois, but he dismissed his case days before the trial in Aug. 2022. Reportedly, several generic manufacturers had offered settlements totaling $500,000 in the months leading to trial.
In December 2022, a judge dismissed all the cases in the Florida MDL, citing a lack of quality evidence. Plaintiffs are appealing.
Types of Cancer Linked to Zantac
Cancer is not one of the typical Zantac side effects. But the NDMA in the drug may increase the risk of several types of cancer.
Studies have linked ranitidine to elevated diagnosis rates of several types of cancer, but so far scientists haven’t definitively said that Zantac causes cancer.
The FDA has determined that NDMA levels increase in some ranitidine products over time. The agency found NDMA levels were greater when more time had passed since the drug was manufactured.
New FDA studies also confirmed significant increases in NDMA levels when samples were stored at higher temperatures. Levels increased under normal storage conditions and at temperatures products may be exposed to during distribution and handling by consumers.
“These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” the FDA concluded.
What Did Earlier FDA Tests Find?
Based on its initial tests, the FDA said NDMA levels in ranitidine were “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
The agency measured NDMA in samples of ranitidine in parts per million. Several lots tested from different manufacturers contained NDMA levels higher than the recommended daily limit of 0.32 ppm.
“The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels,” the agency said about its earlier tests. “At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines.”
The FDA continued its investigation, and in September 2019, the agency warned the public of the potential risks and urged patients and consumers to consider other treatment options.
In its April 2020 announcement, the FDA said the new studies raised concerns that use of ranitidine may expose consumers to unacceptable levels of NDMA.
Levels of NDMA in Initial FDA Tests
|Ajanta Pharma USA Inc||Rx Ranitidine 300 mg||0.23|
|Amneal Pharmaceuticals||Ranitidine 300 mg||0.52-2.17|
|Aurobindo||Rx Ranitidine 300 mg||1.86|
|Cardinal Health||OTC Ranitidine 150 mg||1.02|
|Dr. Reddy's||Rx Ranitidine 300 mg||0.68|
|Novitium||Rx Ranitidine 300 mg||2.85|
|Pharma Associates||Ranitidine 150 mg Syrup||0.03-0.07|
|Sandoz||Rx Ranitidine 300 mg||0.82|
|Sanofi Pharmaceutical||OTC Ranitidine 150 mg||0.07-2.38|
|Sanofi Pharmaceutical||OTC Ranitidine 75 mg||0.10-0.55|
|Sanofi Pharmaceutical||Ranitidine 150 mg||0.08-2.17|
|Silarx Pharma||Ranitidine 150 mg Syrup||1.37|
|Strides Shasun Ltd||Rx Nizatidine 150 mg||0.11|
|Strides Shasun Ltd||Rx Ranitidine 300 mg||0.09|
|Strides Shasun Ltd||Rx Ranitidine 300 mg||0.11|
|Strides Shasun Ltd||Rx Ranitidine 300 mg||0.02|
|Watson||Rx Nizatidine 150 mg||0.05|
|Watson||Rx Ranitidine 300 mg||0.04|
What to Do if You Were Previously Taking Ranitidine
The FDA has issued an immediate market withdrawal, and there won’t be any more products with ranitidine on the market in the U.S.
Because of the potential for increased cancer risk, the FDA does not think it’s safe to continue taking ranitidine products. If you are taking prescription ranitidine, don’t stop taking it without speaking to your doctor.
If you have any questions about your cancer risk or are worried about cancer symptoms, please talk to your health care provider.
- Stop taking OTC ranitidine, properly dispose of any remaining supply, don't buy more and consider using other approved OTC products
- Speak with a health care provider about alternatives before stopping prescription ranitidine
- Do not take medicines to a drug take-back location in light of the current COVID-19 pandemic; instead, follow the specific disposal instructions in the medication guide or package insert
FDA-recommended alternatives to Zantac include: Prilosec (omeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Pepcid (famotidine) and Tagamet (cimetidine).
Sanofi recently released a new OTC formula for Zantac360 made with famotidine instead of ranitidine.
In addition to medications, some patients may be able to control mild heartburn with diet and lifestyle changes.
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