Why Did The FDA Recall Zantac?

Zantac, the popular solution to reduce stomach acid and treat Gastroesophageal Reflux Disease (GERD), Zollinger-Ellison syndrome, as well as treat and even prevent ulcers in the stomach and intestines, has been recalled along with many of the generic versions of both over-the-counter and prescription versions of the drug.

removing zantac and generics from medicine cabinet

On April 1, 2020, the FDA recommended that Zantac, and all Zantac generics, be taken off the market. The FDA found that “they’re a ticking time bomb”, saying they have been exposing consumers to the risk of cancer due to the presence of the contaminant N-Nitrosodimethylamine (NDMA). The following 16 brands voluntarily removed their Zantac/Ranitidine products. If you have any of these products in your medicine cabinet, consult your physician to see if you can stop taking them immediately.

Sandoz Inc. – Ranitidine Hydrochloride Capsules
Apotex Corporation – Ranitidine Tablets
American Health Packaging – Ranitidine Tablets
Mylan Pharmaceuticals Inc. – Nizatidine Capsules
Northwind – Ranitidine Tablets 150mg and 300mg
ani – Ranitidine Tablets 150mg and 300mg
Glenmark – Ranitidine Tablets 150mg and 300mg
Amneal – Ranitidine Tablets and Ranitidine Syrup
PrecisionDose – Ranitidine Oral Solution
GSMS Incorporated – Ranitidine HCl 150mg and 300mg Capsules
AHP – Ranitidine Liquid Unit Dose Cups
Aurobindo & DG Health – Ranitidine Tablets
Novitium Pharma – Ranitidine Hydrochloride Capsules
Lannett Company, Inc. – Ranitidine Syrup
Dr. Reddy’s – Ranitidine Tablets & Capsules
Sanofi – Zantac 150, Zantac 150 Cool Mint, Zantac 75
Perrigo Company plc – Ranitidine tablets

FDA Warning April 1, 2020

The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity.

What Is NDMA And How Much NDMA Does Zantac And Its Generic Forms Contain?

Ranitidine contains NDMA (N-Nitrosodimethylamine) which is an environmental contaminant found in small amounts in water and foods such as vegetables, grilled meats, and dairy products. It has been classified as a probable carcinogen based upon animal studies.

The FDA has determined that people should consume no more than 96 nanograms of NDMA per day. The Valisure Pharmaceutical Company tested individual tablets of Zantac sold over-the-counter and found more than 2.5 million nanograms of NDMA in Zantac and 3.26 million nanograms of NDMA in Zantac Cool Mint from CVS, as well as others that contain more than 3 million nanograms per tablet.

The Valisure Citizen’s Petition states that heat from manufacturing can create high levels of N-Nitrosodimethylamine (NDMA). Another testing lab, Emery Pharma, filed a Citizen Petition saying its testing shows that the level of the suspected carcinogen NDMA can increase if the drug is exposed to high heat, even after it has been packaged.

“Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer,” the petition says.

If You Developed Cancer After Taking Zantac Contact Us Today at 843-352-1440 For a Free Zantac Lawsuit Evaluation!

History of Zantac

Glaxo Holdings Ltd (now known as GSK or GlaxoSmithKline) is the original developer of Zantac, first on the market in 1983. While they applied for long-term use of their product, the original FDA approval was for short-term use. It is being questioned as to why the FDA stipulated (at first) only short-term use. In light of recent findings on the relationship between NDMA and cancer it has been speculated that the FDA may have had cancer concerns for long-term use. In fact, the recent Valisure Citizen’s Petition conducted many studies showing that the dimethylamine in Zantac can be converted, when exposed to stomach acids containing nitrates, to the carcinogenic compound NDMA leading to an early warning that Zantac should not be taken with foods, especially many common foods known as nitrosamines, nitrites and nitrates, such as found in cured meats, bacon, ham, salami, corned beef and hot dogs, pate, pickled pig’s feet, canned meat (Vienna sausages, deviled ham), smoked salmon, dried fish, jerky, beet root, or even spinach and some dairy products.

In 1983 before Zantac was put on the market and 36 years before the recall, two Italian medical studies uncovered the possible link between ranitidine (Zantac), and the carcinogenic molecule NDMA. Even then, scientists were concerned about the creation of the NDMA compound and suggested including Vitamin C in Zantac to prevent cancer since Vitamin C was known as a nitrate “scavenger”. In other words, it neutralizes nitrates. That means that in 1983 before Zantac was released, scientists were so concerned about the creation of the NDMA in stomach acids containing nitrates that they suggested including Vitamin C in Zantac to prevent cancer.

Is Zantac NDMA Contamination Linked to a Specific Type of Cancer?

As more information surfaces regarding the Zantac cases, more information will most likely be uncovered related to the types of cancer that may be caused by taking Zantac. It is important to consult an attorney if you have developed any type of cancer and have taken Zantac, but currently the greatest amount of investigation involves gastric and stomach cancers.

What Are The Possible Side Effects Of Zantac (Ranitidine) And Its Generic Forms?

The most common side effects of Zantac (ranitidine) oral tablets can be: headache, constipation, diarrhea, nausea and vomiting, or stomach discomfort or pain.

Less common, but more severe side effects of Zantac (ranitidine) include stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), fever, chills, cough with mucus, chest pain, feeling short of breath, fast or slow heart rate, easy bruising or bleeding, or problems with your skin or hair. If you have any of these side effects you should stop use and call a doctor immediately.

If you have signs of an allergic reaction to Zantac such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat you should get emergency medical help right away. If you overdose on Zantac, call the Poison Help Line 1-800-222-1222. Overdose symptoms include feeling light-headed, fainting, or having a lack of coordination.

If you have been taking Zantac or its generic forms you should consult your doctor and ask about other alternatives to deal with your condition.

What is Statute of Limitations For Someone Diagnosed With Cancer That Has Taken Zantac?

The Statute of Limitations to sue the drug manufacturers of Zantac depends upon the state in which you live. In most states, cancer victims have one or two years after getting diagnosed to sue. For those who were diagnosed before the Zantac recall, the Statute of Limitations began in 2019. In South Carolina, for instance, a victim has three years from the day of diagnosis or from the year 2019.

What Type of Legal Action Can I Take?

Cancer patients or people with Zantac-related injuries wanting to take legal action are being combined into an MDL (multi-district litigation), which is different from a class action lawsuit. You can contact us at any time to learn about the actions you can take or read our article, “Why Is There A Zantac Cancer Lawsuit?” for more in depth information.

Hiring A Zantac Lawyer, Settlements and Amounts

Many lawyers accept clients with a “no payment unless successful” stipulation, so hiring that firm is risk-free to the client. The lawyer’s fee is usually between 33 1/3% and 40% of the settlement amount. Since the FDA “Zantac recall” and lawsuits against the manufacturers of Zantac and its generics is still in its earliest stages, no settlements have been completed. Your lawyer will be able to give you information about the amount and possibility of a settlement.