Drug makers issued voluntary recalls for Zantac and its generic, ranitidine, because the medicines may contain N-Nitrosodimethylamine, or NDMA, a chemical that may cause cancer. The U.S. Food and Drug Administration has recommended that manufacturers recall any lots that contain levels above the acceptable daily intake of 96 nanograms, or 0.32 parts per million. Several other countries have issued ranitidine bans, recalls or warnings.
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.
As of the latest Zantac recall update on Jan. 8, 2020, fourteen companies have issued generic 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 23, 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.
Manufacturers and Products Affected by Recall
As of Jan. 8, 2020, more than a dozen manufacturers have 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 are 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 have recalled the product in the United States as of Feb. 21, 2020. For detailed information on all lots 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 150mg capsules, 300mg capsules and 15mg/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 issued a voluntary recall for its 150 mg/10 mL ranitidine syrup. The company said it detected trace amounts of NDMA.
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 150mg capsules and 12 lots of ranitidine HCl 300mg 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 150/10 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 150mg 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.
In humans, the most common signs of acute NDMA poisoning are stomach cramps, nausea and vomiting. These effects can occur within hours, according to studies from the U.S. National Library of Medicine’s Toxicology Data Network. Headaches, fever and weakness may also occur, followed by jaundice and enlargement of the liver.
FDA Recommendation and Test Results
The FDA has not told people to stop taking their medication, but it does suggest some options for people who are concerned about NDMA.
- Continue taking ranitidine that has not been recalled. Not all lots of the drug are recalled in the U.S.
- Patients taking prescription ranitidine can talk to their health care providers about alternatives to Zantac and its generics.
- People taking OTC ranitidine can take other OTC heartburn drugs.
What Did FDA Tests Find?
Based on its own tests, the FDA says NDMA levels in ranitidine “are 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.
|Ajanta Pharma USA Inc||Rx Ranitidine 300mg||0.23|
|Amneal Pharmaceuticals||Ranitidine 300mg||0.52-2.17|
|Aurobindo||Rx Ranitidine 300mg||1.86|
|Cardinal Health||OTC Ranitidine 150mg||1.02|
|Dr. Reddy's||Rx Ranitidine 300mg||0.68|
|Novitium||Rx Ranitidine 300mg||2.85|
|Pharma Associates||Ranitidine 150mg Syrup||0.03-0.07|
|Sandoz||Rx Ranitidine 300mg||0.82|
|Sanofi Pharmaceutical||OTC Ranitidine 150mg||0.07-2.38|
|Sanofi Pharmaceutical||OTC Ranitidine 75mg||0.10-0.55|
|Sanofi Pharmaceutical||Ranitidine 150mg||0.08-2.17|
|Silarx Pharma||Ranitidine 150mg Syrup||1.37|
|Strides Shasun Ltd||Rx Nizatidine 150mg||0.11|
|Strides Shasun Ltd||Rx Ranitidine 300mg||0.09|
|Strides Shasun Ltd||Rx Ranitidine 300mg||0.11|
|Strides Shasun Ltd||Rx Ranitidine 300mg||0.02|
|Watson||Rx Nizatidine 150mg||0.05|
|Watson||Rx Ranitidine 300mg||0.04|
Please seek the advice of a medical professional before making health care decisions.