Companies began recalling certain lots of Zantac (ranitidine) after they found traces of NDMA, a known carcinogen. On April 1, 2020, the FDA expanded the Zantac recall and requested that manufacturers immediately withdraw all prescription and over-the-counter ranitidine products from the market, citing new studies that show a risk to public health.
The Zantac recall affects about 15 million Americans who take the prescription strength drug and millions more who take over-the-counter versions, according to a report by Wired.
Sandoz was the first company to issue a voluntary recall for generic ranitidine on Sept. 24, 2019. Other generic manufacturers soon followed.
At first, Sanofi — the manufacturer of brand-name 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.”
Then on Oct. 18, 2019, Sanofi said it was issuing a voluntary recall of brand-name Zantac OTC, the over-the-counter formula of the drug, in the United States and Canada.
By March 27, 2020, a total of 15 companies had issued ranitidine recalls in the United States, according to the FDA’s Recalls, Market Withdrawals, & Safety Alerts.
In addition to the U.S., about 43 other countries and jurisdictions have responded to the news of contamination by issuing bans, recalls or warnings, according to Bloomberg. These countries include Canada, Germany, France, Ireland, UK, Australia, New Zealand, Japan, Indonesia, Greece, South Korea, Taiwan, Italy, Norway and Namibia.
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.
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 and Products Affected by Recall
As of March 27, 2020, more than a dozen manufacturers had recalled ranitidine products in the United States.
After the recalls people filed Zantac lawsuits against Sanofi and Pfizer, the drug’s manufacturers and marketers. These lawsuits claim drug makers knew the NDMA in ranitidine could increase the risk of cancer but did not warn the public. As of February 2019, at least 140 cases had been consolidated in multidistrict litigation in Florida.
In their recall announcements on the FDA’s website, manufacturers list either the Zantac recall lot numbers or the National Drug Codes, abbreviated NDC. The NDC provides information such as what company labeled the drug, the type of medication and the number of doses in a package. A pharmacist can help consumers find this information on their medication packaging.
Below is a list of manufacturers that had recalled the product in the United States as of March 27, 2020. For detailed information on all lot numbers and NDC codes, please check the company’s recall announcements on the FDA’s page for Recalls, Market Withdrawals and Safety Alerts.
The Sandoz recall issued on Sept. 23, 2019 affects 150 mg and 300 mg doses of ranitidine in 20, 60 and 500 count bottles. Consumers can ask their local pharmacists for help identifying recalled lot numbers.
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.
The recall affects ranitidine tablets in 75 mg, 150 mg and 300 mg strengths packaged in counts from 24 to 500. All ranitidine products with expiration dates September 2019 to March 2022 are included in the recall.
For the full list of NDC codes, check the company’s announcement on the FDA website.
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.
The company issued a recall on October 25 for all products with the expiration dates October 2019 to August 2021 under NDC code 54838-550-80.
For a full list of lot numbers, check the company’s announcement on the FDA website.
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.
For a full list of lot numbers, check the company’s announcement on the FDA website.
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. For a full list of lot numbers, check the company’s announcement on the FDA website.
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.
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.
Cancer is not a typical Zantac side effect. But the NDMA in the drug may increase the risk of several types of cancer, such as bladder and liver cancer.
FDA Recommendations and Test Results
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.
- Stop taking OTC rantidine, 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
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.”
|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|
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.
Please seek the advice of a medical professional before making health care decisions.