Zantac Recall: FDA Recalls All Zantac & Ranitidine Products

On April 1, 2020, The Food and Drug Administration (FDA) requested the recall of all Zantac and ranitidine products from the U.S. market due to contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA).

Do I Have A Case?

Why Is The FDA Recalling All Zantac Products?

The FDA Zantac recall announcement acknowledges that NDMA impurities in the popular heartburn medications can increase to dangerous levels when the products are stored over time or exposed to higher temperatures. This determination echoes the findings reported to the FDA earlier this year by Emery Pharma, which found steady increases of NDMA production in Zantac and ranitidine products stored just above room temperature. Emery’s study also produced levels of NDMA exceeding the FDA’s daily acceptable intake limit of 96 nanograms in ranitidine products stored in temperatures as low as 158 degrees Fahrenheit for as little as five days.

Emery submitted these findings to the FDA in a Citizen Petition on January 2, 2020 and recommended the agency recall all Zantac and ranitidine products from the market. Additional testing has since found that older ranitidine products contained greater levels of NDMA, suggesting that NDMA levels in the drugs can increase over time.

Is This The First Zantac Recall?

No. The FDA has announced 16 different recalls of Zantac and ranitidine products since tests began discovering NDMA in the heartburn medications in September 2019. Until now, the agency had refrained from withdrawing all Zantac and ranitidine products from the market due to inconsistencies in NDMA levels found in previous tests. However, the FDA has now concluded that it can no longer guarantee the safety of the products due to unknowns about duration and conditions in which the drugs have been stored.

What Should I Do If I Am Currently Taking Zantac?

The FDA is recommending users of over-the-counter Zantac and ranitidine products to cease use immediately and safely dispose of any remaining medication. The agency advises patients taking prescription ranitidine products to speak with their healthcare provider to discuss alternative treatment options.

What Is NDMA and Why Is It Dangerous?

NDMA is considered a probable human carcinogen by multiple global health organizations. It was previously used to make rocket fuel, however, this was stopped after unusually high levels of the compound were found in the air, water, and soil samples collected near a rocket fuel manufacturing plant. NDMA is now only intentionally produced in the U.S. for research purposes.

Human exposure to unsafe levels of NDMA in Zantac and ranitidine products has been linked to the following cancers:

  • Bladder Cancer
  • Stomach Cancer
  • Intestinal Cancer
  • Colon/Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer
  • Prostate Cancer
  • Esophageal Cancer
  • Pancreatic Cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma

How We Can Help

GoldenbergLaw is currently representing clients who have been diagnosed with cancer after taking Zantac or ranitidine products. The Zantac Recall Attorneys at GoldenbergLaw have over 30 years of experience delivering justice to victims of corporate negligence. If you are interested in learning more about a Zantac recall lawsuit, contact us today for a free consultation. Let us delivery the Gold standard advocacy you deserve.

Does Heat Produce the Carcinogen Found in Zantac? New Study Says Yes

New testing from a California pharmacy has found elevated levels of the probable human carcinogen NDMA in Zantac when the drug is exposed to heat. As a result of its troubling findings, Emery Pharma has filed a Citizen Petition with the Food and Drug Administration (FDA) requesting the agency pull all products containing ranitidine, Zantac’s active ingredient, from the market immediately. The FDA began announcing individual Zantac and ranitidine recalls in September 2019, and the agency announced a universal Zantac recall on April 1, 2020.

Do I Have A Case?

Does Heat Produce NDMA?

Emery tested multiple samples of ranitidine stored in different conditions over different periods of time. Samples stored for five days at 158 degrees Fahrenheit were found to contain 142 nanograms of NDMA, well over the FDA’s acceptable limit of 96 nanograms. Equally concerning, samples stored at temperatures as low as 77 degrees Fahrenheit showed a steady increase of NDMA production up to 25 nanograms after 12 days. The latter finding falls under the FDA’s threshold for acceptable levels of NDMA intake, however it raises the possibility that levels could continue to raise over longer periods of time at that temperature.

The results were troubling enough for Emery’s CEO to suggest that even something as simple as leaving the drug in a hot car could lead to NDMA production. “The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi told Bloomberg News. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”

Why Is This Important?

The most concerning element to Emery’s findings is that NDMA can be produced in ranitidine products after passing through testing done by the manufacturer. Since September 2019, the FDAzantac-bottle has been asking pharmaceutical companies to test Zantac and ranitidine products for NDMA contamination prior to putting them on the market. As of April 2020, over 15 different manufacturers and repackaging companies have recalled some or all lots of the Zantac and ranitidine products they produce due to NDMA contamination.

Emery’s findings suggest that Zantac and ranitidine products that have been deemed safe for consumption could still produce enough NDMA to be dangerous if exposed to certain conditions.

Why Is NDMA Dangerous?

 According to the World Health Organization, NDMA is a probable human carcinogen, or a substance that causes cancer, that can be found in drinking water in generally harmless levels through the degradation of dimethylhydrazine (component of rocket fuel). NDMA can also be found in tanneries, pesticide manufacturing plants, and rubber and tire manufacturing facilities.

NDMA exposure in Zantac and ranitidine has been linked to cancers such as:

  • Bladder Cancer
  • Stomach Cancer
  • Intestinal Cancer
  • Colon/Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer
  • Prostate Cancer
  • Esophageal Cancer
  • Pancreatic Cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma

Who Is Emery Pharma?

Emery Pharma is an independent laboratory based out of Alameda, California. Emery was hired to conduct these tests by the online pharmacy Valisure, LLC, which had originally petitioned the FDA to recall Zantac and ranitidine products in September 2019. Valisure is an online pharmacy company that launched in 2018 as a pharmacy, lab, and wholesaler. Valisure is licensed in 38 states and regularly analyzes the safety of 2,000 different pharmaceutical products in order to increase individual quality control to the pharmaceutical testing industry.

How Was NDMA Discovered in Zantac?

Once the FDA discovered NDMA and other carcinogens in Angiotensin II Receptor Blocker (ARB) drugs such as Valsartan, Losartan, and Irbesartan, Valisure added more product tests for carcinogens to its testing panels, and one of the first compounds it tested was ranitidine. Valisure’s analysis turned up “extremely concerning results” of 3 milligrams of NDMA, far exceeding the acceptable limits of 96 nanograms per day, in a single 150-mg tablet of ranitidine.

Valisure’s testing found that Zantac is not necessary “contaminated” with NDMA; rather, the carcinogen is produced by the breakdown of the ranitidine molecule during digestion. Valisure CEO David Light explains that “the fundamental problem is that it’s an unstable molecule. The drug itself can directly degrade and form, with very high efficiency, NDMA.” Therefore, Zantac’s NDMA contamination is not specific to a certain manufacturer or batch; it can occur within any ranitidine molecule when exposed to the right conditions.

What Is The FDA Saying?

On April 1, 2020, the FDA recommended the recall of all Zantac and rantidine products from the U.S. market. Previously, the agency had been investigating NDMA contamination of Zantac and ranitidine products since Valisure’s petition in September 2019. Upon analyzing Valisure’s initial findings, the FDA opened an investigation and challenged Valisure’s high-heat testing method that involves heating the compound to 266 degrees Fahrenheit. Instead, the FDA used a lower-heat testing method known as the Liquid Chromatography- High Resolution Mass Spectrometry Method (LC-HRMS) when evaluating ranitidine. Despite using the LC-HRMS, international agencies including the FDA have still found unacceptably high levels of NDMA in ranitidine products.

Countries such as Canada, Germany, France, Italy, Switzerland, and Austria had already recalled ranitidine drugs. In addition, major U.S. drug retailers such as CVS, Walmart, Walgreens, Kroger, and Rite-Aid had removed all ranitidine medications, including name brand Zantac, from their stores.

How We Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the digestive cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.

What You Should Know About The FDA Recall of Zantac

On April 1, 2020, The Food and Drug Administration (FDA) recommended the universal recall of all Zantac and ranitidine products from the U.S. market. The Zantac recall comes after various third party tests have found that unsafe levels of the probable human carcinogen NDMA can be produced in Zantac and ranitidine products as they are stored over time or when they are exposed to high temperatures.  The FDA Zantac recall includes both prescription and over-the-counter Zantac and ranitidine products.

Do I Have A Case?

Zantac has been on the market for over thirty years and millions of people have taken brand name product and its generic, ranitidine. For anyone currently taking these drugs, you should immediately contact your doctor to discuss your options.

What Is Zantac?

Zantac is a medication that limits the production of stomach acid and belongs to a class of medications known as H2 blockers. It is sold as a generic under the name of its active ingredient, ranitidine. Zantac is sold over-the-counter to treat heartburn and acid indigestion, and prescribed for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease, and certain stomach and esophagus conditions.

What Is NDMA?

NDMA is classified as a probable human carcinogen that can form as a byproduct of industrial processes or, as in Zantac, from exposure to high temperatures or storage over time. The chemical can be found in small quantities in drinking water but in levels that are considered generally harmless. The NDMA found in the recalled Zantac and ranitidine products is above levels considered safe by the FDA. NDMA had previously been found in the blood pressure medication Valsartan, which prompted a string of product recalls starting in July 2018.

NDMA exposure in Zantac and ranitidine has been linked to digestive system cancers such as:

  • Stomach cancer
  • Intestinal cancer (both of the small and large intestines)
  • Esophageal cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Bladder cancer
  • Stomach cancer
  • Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer

Additionally, in babies born to mothers who took Zantac consistently throughout their pregnancies, NDMA has been linked to cancers, including brain cancers, in young children.

Zantac Recall Summary

Appco Pharma Ranitidine Recall

On January 8, 2020, Appco Pharma LLC announced a voluntary recall of all lots of its Ranitidine Hydrochloride capsules due to potential NDMA contamination. The recall includes all prescription Ranitidine Hydrochloride capsules in strengths of 150 mg and 300 mg manufactured and distributed by Appco and its marketing partner, ANI Pharmaceuticals.

Northwinds Pharmaceuticals Ranitidine Recall

On January 8, 2020, Denton Pharma, an affiliate of Northwind Pharmaceuticals LLC, voluntarily recalled all lots of prescription Ranitidine 150 mg and 300 mg tablets it had repackaged and distributed at the consumer level.  The recall in is response to the manufacturer’s recall of these medications, which had since been repackaged by Denton Pharma, due to concerns of potential NDMA contamination.

Glenmark Pharmaceuticals Ranitidine Recall

On December 17, 2019, Glenmark Pharmaceuticals Inc. issued a voluntary recall of its unexpired Ranitidine tablet products and halted product distribution due to worries over potential NDMA contamination. In total, 928 lots of Ranitidine 150mg and 300 mg tablets are affected in the recall.

Precision Dose Ranitidine Recall

On November 19, 2019, repackaging company Precision Dose Inc. voluntarily recalled 5 lots of Ranitidine Oral Solution–USP 150mg/ 10mL from the market. The ranitidine product is being recalled due to potential NDMA presence above the standards approved by the Food and Drug Administration.

The recall was initiated after manufacturer Amneal Pharmaceuticals, LLC) issued a voluntary recall which included lots repackaged by Precision Dose Inc.

Golden State Ranitidine Recall

On November 15, 2019, repackaging company Golden State Medical Supply, Incorporated (GSMS, Inc.) voluntarily recalled all quantities and lots of Ranitidine HCl 150mg and 300mg capsules due to the potential presence of NDMA above levels approved by the Food and Drug Administration.

The voluntary recall comes after GSMS, Inc received a recall notice from manufacturer Novitium on October 25, 2019 and initially recalled 7 lots of Ranitidine HCl 150mg and 12 lots of Ranitidine HCl 300mg capsules on November 6, 2019.

American Health Ranitidine Recall

On November 8, 2019, American Health Packaging voluntarily recalled 8 lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150mg/10mL Liquid Unit Dose Cups from the consumer market due to an “unexpected impurity” of NDMA detected in the finished products at levels deemed unsafe by the Food and Drug Administration.

The recall comes in response to manufacturer Lannett Company, Inc.’s voluntary recall of ranitidine products which included affected lots that were repackaged by American Health Packaging.

Amneal Ranitidine Recall

On November 8, 2019, Amneal Pharmaceuticals, LLC voluntarily recalled Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL that were distributed directly to wholesalers, distributors, retailers, and re-packagers due to potential NDMA levels deemed unacceptable by Food and Drug Administration standards.

Lannett Ranitidine Recall

On October 28, 2019 the FDA announced that Lannett Company, Inc. recalled all lots of its prescription ranitidine syrup. The recall includes Lannett’s ranitidine oral solution prescribed in 15mg/mL doses due to the confirmed presence of NDMA.

Novitium Pharma Ranitidine Recall

On October 25, 2019, the FDA confirmed that Novitium Pharma LLC recalled all lots of its over-the-counter Ranitidine Hydrochloride capsules in the United States. Novitium’s ranitidine recall includes all lots of 150 mg and 300 mg dosages sold in 30, 60, 100, and 500 count bottles. The FDA announcement states that the recall was due to potential unsafe levels of NDMA found in the capsules.

Perrigo Ranitidine Recall

On October 23, 2019, the FDA announced that Perrigo Company plc issued a worldwide recall of all lots of its over-the-counter ranitidine products. The announcement states that Perrigo halted shipments of its ranitidine products on October 8 due to the possible presence of NDMA. The Perrigo recall includes many popular ranitidine products, including the Publix over-the-counter store brand.

Dr. Reddy’s Ranitidine Recall

On October 23, 2019, the FDA announced that Dr. Reddy’s Laboratories, LTD. issued a voluntary recall of all lots of its ranitidine products – both prescription and over-the-counter – sold in the United States on October 1. This recall includes lots of ranitidine sold under store brand names at Walgreens, Target, Walmart, Kroger, and CVS. The ranitidine recall was initiated after product testing confirmed unsafe levels of NDMA. For a full list of products recalled under the Dr. Reddy’s ranitidine recall, visit the FDA recall page.

zantac-pill-containersSanofi Zantac OTC Recall

The FDA also confirmed on October 23, 2019 that Sanofi recalled all lots of its Zantac OTC (over-the-counter) medications sold in the United States and Canada on October 18. The company cited “inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products” as the reason for the recall. The Sanofi Zantac OTC recall includes all lots of Zantac 150, Zantac 150 Cool Mint, and Zantac 75.

Apotex Ranitidine Recall

On September 25, 2019, the FDA announced that Apotex Corp. voluntarily recalled its over-the-counter Ranitidine Hydrochloride tablets on a precautionary basis due to concerns of NDMA contamination. The Apotex ranitidine recall applied to 75 mg and 150 mg tablets sold under store brand names at Rite Aid, Walmart, and Walgreens pharmacies.

Sandoz Ranitidine Recall

On September 23, 2019, the FDA announced that Sandoz Inc. recalled all lots of its Ranitidine Hydrochloride capsules sold over-the-counter in the United States due to confirmed NDMA contamination. Sandoz is a subsidiary of the Swiss pharmaceutical conglomerate Novartis. The Sandoz ranitidine recall applies to 14 lots of Ranitidine 150 mg and 300 mg capsules sold in 30, 60, and 500 count bottles.

How We Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.