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                Drug Safety and Availability

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          FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)Drug Safety and Availability FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
  
  	
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    Print4/16/2020: UPDATE - FDA alerts patients and health care professionals to Amneal’s voluntary recall of nizatidine
	**Update [4/16/2020]** FDA is alerting patients and health care professionals to Amneal Pharmaceutical’s voluntary recall of nizatidine oral solution (15 mg/mL). The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

FDA has advised companies to recall their nizatidine if testing shows levels of NDMA above the acceptable daily intake limit (96 nanograms per day). The agency posted the results of its testing of nizatidine samples and has asked companies to conduct their own laboratory testing.

Patients taking prescription nizatidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as nizatidine.

4/1/2020: PRESS RELEASE - FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
	Go to FDA Press Release

2/27/2020: UPDATE - FDA alerts patients and health care professionals to American Health Packaging’s voluntary recall of ranitidine
	**Update [2/27/2020]** FDA is alerting patients and health care professionals to American Health Packaging’s voluntary recall of ranitidine tablets (150 mg), manufactured by Amneal Pharmaceuticals, LLC. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

1/8/2020: UPDATE - FDA alerts patients and health care professionals to two voluntary recalls of ranitidine
	**Update [1/8/2020]**FDA is alerting patients and health care professionals to two voluntary recalls of ranitidine. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

Appco Pharma LLC is voluntarily recalling prescription ranitidine hydrochloride capsules.
	Northwind Pharmaceuticals is voluntarilyrecalling prescription ranitidine tablets (150 mg and 300 mg), manufactured by Glenmark Pharmaceutical Inc.FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

1/8/2020: STATEMENT – FDA alerts health care professionals and patients to Mylan’s voluntary recall of nizatidine
	**Update [1/8/2020]**The U.S. Food and Drug Administration is alerting health care professionals and consumers to Mylan’s voluntary recall of prescription nizatidine capsules. The medicines may contain unacceptable levels of the nitrosamine, N-nitrosodimethylamine (NDMA). Nizatidine is a commonly prescribed antacid.

NDMA is a known environmental contaminant found in water and certain foods. Genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.

In September 2019, FDA announcedit had become aware of laboratory testing that found low levels of NDMA in the heartburn medicine, ranitidine, which is chemically similar to nizatidine. FDA has been testing samples of both ranitidine and nizatidine.  The agency has also asked manufacturers of the drugs to conduct their own laboratory testing to assess levels of NDMA in their products and to send samples to FDA to be tested by our scientists. FDA will recommend recalls to manufacturers of ranitidine and nizatidine with NDMA levels above the acceptable daily intake limit (96 nanograms per day).

There are multiple drugs that are approved for the same or similar uses as ranitidine and nizatidine. Patients taking prescription ranitidine or nizatidine who wish to stop use should talk to their health care professional about other treatment options. If you are taking one of the recalled medicines, you should follow the recall instructions provided by the company. This information is on the FDA’s website.

FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since 2018. FDA has recommended numerous recalls of ARBs as it discovered unacceptable levels of nitrosamines.

FDA is committed to helping assure the medicines Americans take are safe and effective. When we identify lapses in the quality of drugs that pose potential risks for patients, FDA makes every effort to understand the issues and provide our best recommendation to the public as quickly and accurately as possible.

FDA will continue to investigate and work to make certain these types of impurities do not exceed acceptable limits, so that patients can continue taking their medicines without concern. The agency will provide timely updates throughout the investigation.

FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reportingprogram:

Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
	Download and complete the form, then submit it via fax at 1-800-FDA-0178

12/18/2019: UPDATE - FDA alerts patients and health care professionals to Glenmark’s voluntary recall of ranitidine
	**Update [12/18/2019]** FDA is alerting patients and health care professionals to Glenmark Pharmaceutical Inc.’s voluntary recall of prescription ranitidine tablets (150 mg and 300 mg). The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

12/4/2019: UPDATE – FDA requires additional testing of ranitidine and nizatidine as part of agency’s ongoing effort to help ensure product safety for patients and consumers
	**Update [12/4/2019]** Over the past several weeks, FDA has communicated about the detection of an impurity known as N-nitrosodimethylamine (NDMA) in common heartburn medications (ranitidine, commonly known as Zantac, and nizatidine) available over the counter or by prescription. We have launched an investigation to understand the cause of this impurity in these drugs and to provide information for patients and consumers who take them. As part of this investigation, we have asked manufacturers to conduct their own laboratory testing to examine levels of NDMA in ranitidine and nizatidine and to send us samples to be tested by our scientists.

Today, we are announcing that we have asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use.

We continue to work with industry and regulatory agencies around the world to determine the reasons for NDMA in these drugs and have developed and posted multiple testing methods to identify NDMA in ranitidine. Our scientists have determined ranitidine does not form NDMA in typical stomach conditions. However, we need further investigation to fully test how ranitidine and nizatidine behave in the human body and have plans to study this. There is also some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present. Because of this, consumers who wish to continue taking these drugs should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite.

Consumers may also consider alternative treatments that are approved for the same or similar uses as ranitidine and nizatidine. To date, FDA’s testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole).

11/22/2019: UPDATE – FDA alerts patients and health care professionals to two repackagers’ voluntary recalls of ranitidine
	**Update [11/22/2019]** FDA is alerting patients and health care professionals to two repackagers’ voluntary recalls of ranitidine. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

Golden State Medical Supply voluntarily recalled ranitidine capsules (150mg and 300mg), manufactured by Novitium.
	Precision Dose Inc. voluntarily recalled ranitidine oral solution, USP 150 mg/10 mL, manufactured by Amneal Pharmaceuticals LLC.FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.



Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.



Consumers taking over-the-counter (OTC) ranitidine may consider using other OTC products approved for their condition. FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.

11/12/2019: UPDATE - FDA alerts patients and health care professionals to voluntary recalls of ranitidine
	**Update [11/12/2019]** FDA is alerting patients and health care professionals to two voluntary recalls of ranitidine.

Amneal voluntarily recalled prescription ranitidine hydrochloride tablets (150mg and 300mg) and ranitidine syrup (15mg/mL) manufactured by Amneal Pharmaceuticals LLC. These medications may contain unacceptable levels of N-nitrosodimethylamine (NDMA).American Health Packaging also voluntarily recalled eight lots of ranitidine syrup (150 mg/10 mL) liquid unit dose cups, manufactured by Lannett Company.FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

Consumers taking over-the-counter (OTC) ranitidine may consider using other OTC products approved for their condition. FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.

11/8/2019: UPDATE - FDA alerts patients and health care professionals to Aurobindo’s recall of prescription and over-the-counter ranitidine
	**Update [11/8/2019]** FDA is alerting patients and health care professionals to a voluntary recall of over-the-counter (OTC) ranitidine tablets (150mg), prescription ranitidine capsules (150mg and 300mg) and ranitidine syrup (15mg/mL) manufactured by Aurobindo Pharma USA. These medications contain unacceptable levels of N-nitrosodimethylamine (NDMA).

FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine).

Consumers may not know if the OTC ranitidine in their homes contains NDMA above the acceptable daily intake level because these recalls have been to the retail level, meaning they were only removed from store shelves. The NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.

Consumers taking OTC ranitidine may consider using other OTC products approved for their condition. FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

11/1/2019: STATEMENT - Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research on new testing results, including low levels of impurities in ranitidine drugs
	Go to FDA Statement

11/1/2019: UPDATE - Laboratory testing results for NDMA in ranitidine
	Go to Laboratory Tests | Ranitidine

10/28/19: UPDATE - FDA alerts health care professionals and patients to multiple voluntary recalls of ranitidine
	**Update [10/28/19]** The U.S. Food and Drug Administration is alerting health care professionals and patients to three voluntary recalls of ranitidine.

Perrigo Company plc is voluntarily recalling over-the-counter (OTC) ranitidine tablets (all pack sizes) due to the potential of N-Nitrosodimethylamine (NDMA) in the medicine.
	Novitium Pharma LLC is voluntarily recalling all unexpired quantities and lots of ranitidine hydrochloride capsules due to the potential of NDMA in the medicine.
	Lannett Company, Inc. is voluntarily recalling all unexpired lots of prescription ranitidine syrup (ranitidine oral solution, USP, 15mg/mL) due to the presence of NDMA found in the drug.Refer to the FDA’s recalls webpage for up-to-date information about recalls of ranitidine.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition. FDA’s testing of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these medicines.

10/23/19: UPDATE - FDA releases additional NDMA testing method and alerts health care professionals and patients to multiple voluntary recalls of ranitidine
	**Update [10/23/19]** The U.S. Food and Drug Administration is releasing a second liquid chromatography-mass spectrometry (LC- MS) method for manufacturers and regulators to detect and quantify NDMA in ranitidine. The agency is using this method to test potential NDMA-containing ranitidine samples. The second LC-MS method for NDMA in ranitidine uses a more widely available technology than the first posted method. The agency is sharing the second method to provide alternatives to firms wishing to test their drug products for NDMA.

FDA is also alerting health care professionals and patients to two voluntary recalls of ranitidine:

Dr. Reddy’s Laboratories Ltd is voluntary recalling all prescription and over-the-counter (OTC) ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.
	Sanofi is voluntarily recalling OTC ranitidine due to possible NDMA contamination.Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition. FDA’s preliminary tests of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these tested medicines at this time.

FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes available. See Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) for more information.

10/2/19: UPDATE - FDA provides update on testing of ranitidine for NDMA impurities
	**Update [10/2/19]** FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. In addition, the agency has asked manufacturers of ranitidine to conduct their own laboratory testing to assess levels of NDMA in their ranitidine products and to send samples of ranitidine products to FDA to be tested by our scientists.

FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.

FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. FDA’s LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.

FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation. To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available.

9/26/19: STATEMENT - FDA alerts health care professionals and patients to voluntary recall of ranitidine medicines
	**[9/26/19]**The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. These medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid ingestion and sour stomach, may consider using other OTC products approved for their condition.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

This recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines. The agency also recently alerted patients and health care professionals of Sandoz Inc.’s voluntary recall of prescription ranitidine hydrochloride capsules due to an NDMA impurity on Sept. 23.

What patients should know

Not all ranitidine medicines marketed in the U.S. are being recalled.
	FDA is not recommending individuals stop taking all ranitidine medicines at this time.
	Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
	Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.What health care professionals should know

Multiple drugs are approved for the same or similar uses as ranitidine. Health care professionals should discuss other treatment options with patients who are concerned about ranitidine.
	If you have samples of recalled ranitidine, do not provide them to patients.FDA’s actions

FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking ranitidine. Additionally, FDA recently posted a testing method, which can be used by regulators and industry to detect nitrosamine impurities in ranitidine. FDA has asked ranitidine manufacturers to conduct laboratory testing to examine levels of NDMA in ranitidine and to send samples of ranitidine to the agency to be tested by our scientists.

FDA will take appropriate measures based on the results of this ongoing investigation. Some manufacturers have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other international regulators conduct their investigations of the NDMA impurity.

FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes available.

Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA's MedWatch program to help the agency better understand the scope of the problem:

Complete and submit the report online at www.fda.gov/medwatch/report.htm
	Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

9/24/2019: PRESS RELEASE - FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
	Go to FDA Press Release

9/13/2019 : STATEMENT - Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
	Go to FDA Statement

FDA-published testing method to provide an option for regulators and industry to detect NDMA impurities

The link below is to an FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities in ranitidine drug substances and drug products. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.

LC-HRMS method: an LC-MS method for the detection of NDMA in ranitidine drug substance and drug products
	LC-MS/MS method: An alternative method for the detection of NDMA in ranitidine drug substance and drug products. This method is based on a triple-quadrupole MS platform.

Resources for You

Q & A: NDMA in ranitidine
	Nitrosamine Impurities in Medications

                                                                                  Content current as of:
      04/16/2020
              
              
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				  				  Safety - Issues, Errors, and ProblemsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
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