Van Wey, Metzler & Williams


FDA Issues Mandatory RECALL of ALL Zantac and Ranitidine Products
April 1, 2020

The Food and Drug Administration issued a mandatory recall of all Zantac and Ranitidine products for containing unapproved levels of N-nitrosodimethylamine (NDMA). NDMA is a probable human carcinogen which is a substance that can cause cancer. NDMA can especially cause damage to the liver, kidneys, and stomach when taken in large amounts or over time.

Additional concerns were that the level of NDMA in a product INCREASES OVER TIME regardless of the safety protocols taken when storing the product. This means the already high levels of NDMA when testing the products during manufacturing actually lead to higher levels of the product you buy at the store or get from the pharmacy.

Zantac and other ranitidine products are over-the-counter medications but are also prescribed by doctors in higher dosages for the treatment of heartburn, stomach ulcers, gastroesophageal reflux disease (GERD), and other conditions that cause too much stomach acid. In fact, more than 15 million prescriptions for Zantac are written every year. This is a terrifying number

Although the manufacturers of Zantac and ranitidine products have been initiating voluntary recalls since September of last year, the FDA has never directed that the products be removed from the market altogether UNTIL NOW. The current advice has been to speak with your doctor about an alternative medication.

Due to the nature of NDMA, the effects correlate directly to the amount consumed. In other words, for someone who only occasionally takes the drug, their risk of cancer may be low. To a person who has been taking Zantac daily for years, the accumulated exposure to its carcinogenic ingredients, even in very low amounts, has added up to a higher risk for developing cancer now.

If you or someone you love took Zantac or other ranitidine containing medications for longer than three months, you may be at risk for developing cancer for years to come.

FDA Action Against Zantac

The FDA is continuing to review and investigate the levels of NDMA found in Zantac and similar medications containing ranitidine. In addition, the agency will be investigating and assessing possible effects on patients who have taken the drugs.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We began testing ranitidine products immediately after we learned of the potential impurity. When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said Acting FDA Commissioner Ned Sharpless, M.D. “We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern.”

  • April 1, 2020—FDA issues mandatory recall of all Zantac and Ranitidine products.
  • September 13, 2019NDMA discovered in Zantac in low levels. The FDA released a statement but did not issue a recall pending further investigation.
  • September 23, 2019—Sandoz Inc., a manufacturer of Zantac and other drugs containing ranitidine, issued a voluntary recall for the following products:
    • Ranitidine 150mg Capsules 500 count—various lots with expiration dates of 4/30/2020 or 9/30/2020
    • Ranitidine 150mg Capsules 60 count—various lots with expiration dates of 4/30/2020, 9/30/2020, or 8/31/2021
    • Ranitidine 300mg Capsules 30 count—various lots with expiration dates of 4/30/2020, 8/31/2020, or 3/31/2021
  • September 26, 2019—the FDA announces 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.
  • October 28, 2019—Lannet Company Inc. issued a voluntary recall for all Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL that was currently out on the market. Novitium Pharma issued a voluntary recall for Ranitidine Hydrochloride Capsules 150 mg and 300 mg in 30,60, 100, and 500 count bottles. Perrigo Company initiated a voluntary, worldwide product recall for all products containing ranitidine.
  • November 1, 2019—the FDA released a summary of additional research on ranitidine stating: “Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines.” The FDA further recommended that consumers speak with their doctors for alternative medication but did not direct consumers to stop taking Zantac or ranitidine products.
  • November 8, 2019—Aurobindo Pharma USA voluntarily recalls ranitidine tablets (150mg), prescription ranitidine capsules (150mg and 300mg) and ranitidine syrup (15mg/mL).
  • November 12, 2019—Amneal voluntarily recalls prescription ranitidine hydrochloride tablets (150mg and 300mg) and ranitidine syrup (15mg/mL).
  • November 22, 2019—Golden State Medical Supply voluntarily recalls ranitidine capsules (150mg and 300mg). Precision Dose Inc. voluntarily recalls ranitidine oral solution, USP 150 mg/10 mL.
  • December 4, 2019—the FDA orders manufacturers to test all lots of medications containing ranitidine for improper levels of NDMA before selling or distributing them. The FDA also, again, suggests consumers speak with their doctors about alternative medications.
  • January 8, 2020—Mylan and Appco Pharma LLC  issue voluntary recalls for all prescription products containing ranitidine. Northwind Pharmaceuticals recalls prescription ranitidine tablets (150 mg and 300 mg).
  • February 20, 2020—American Health Packaging voluntarily recalls ranitidine tablets (150 mg).

What are the Common Symptoms of Zantac Cancer?

Not much is currently known about the long-term effects of exposure to NDMA or how it will present in humans. Animal testing has shown that NDMA is very harmful to the liver and can cause liver cancer or non-cancerous liver disease.

NDMA exposure may also lead to other cancers, notably:

  • Bladder Cancer
  • Kidney Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
  • Stomach Cancer
  • Throat, Nose or Esophageal Cancer
  • Testicular Cancer
  • Brain Cancer
  • Prostate Cancer

Hiring A Zantac Lawsuit Attorney

Our attorneys are currently evaluating and investigating claims on behalf of patients who have been diagnosed with cancer as a potential side effect of taking a known human carcinogen. If you have been diagnosed with cancer or lost a loved one after who developed cancer after taking Zantac, or another ranitidine containing medication, for three months or longer, please contact us immediately.

In many cases, filing a Zantac lawsuit is the only way to recover money that is lost from hospital expenses, lost wages, or even funeral expenses. In other cases, people file lawsuits because they want to make a difference and prevent others from suffering through the same horrors they have.

To discuss the specifics of your potential Zantac lawsuit in a free and confidential consultation, contact us today or submit your case for evaluation below. Let Van Wey, Metzler & Williams help you receive compensation from these irresponsible pharmaceutical companies who place profit over public safety.

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