pharmacist helping male patient with medication

Zantac is the brand name for the drug ranitidine. Ranitidine belongs to a class of drugs called histamine-2 blockers, which relieve and prevent heartburn, as well as ulcers in the stomach or intestines. In addition to brand name Zantac, many companies sell generic versions of the drug.

Why Was Zantac Recalled?

Zantac has been recalled due to a contamination of NDMA. NDMA may cause harmful side effects, including stomach cancer, in humans who consume it. Although NDMA is a common environmental contaminant that people may come into contact with by eating dairy products, vegetables, or grilled or smoked meats, the chemical compound is capable of resulting in adverse side effects if it is consumed in high amounts.

When was Zantac Recalled?

The FDA announced the Zantac contamination on Sept. 13, 2019. In the months since the FDA’s initial report and ranitidine recall, multiple drug companies have announced additional recalls of the drug.

What Zantac Has Been Recalled?

In addition to brand name Zantac, generic Zantac has been recalled by Walgreens, Walmart, and Rite-Aid. Other companies that have recalled ranitidine include Apotex, Sandoz, Appco Pharma, Northwind Pharmaceuticals, American Health Packaging, Dr. Reddy’s Laboratories, Perrigo Company, Aurobindo, and more.

The FDA has recommended companies recall their ranitidine tablets if testing indicates contamination levels higher than the acceptable daily intake for NDMA. This acceptable intake level is 96 ng, or 0.32 parts per million. Additionally, some companies that have tested ranitidine and found levels below the acceptable daily intake have still recalled the medications, due to the potential for further contamination. However, the FDA does not recommend patients stopping use of their medication without first visiting with their doctor.

If you are concerned that you may have purchased recalled ranitidine or brand name Zantac, you may be able to check the FDA’s drug recall page and compare your lot numbers against the recalled lots.

How Did the Zantac Contamination Occur?

Concerns about Zantac recalled prompted experts to seek more information about the possible contamination. According to Deseret News, Zantac’s contamination might not be because NDMA got into batches of Zantac. Rather, experts believe that under certain circumstances, Zantac itself may produce NDMA. Emery Pharma conducted a study examining this phenomenon. The research showed that Zantac can convert into NDMA when the drug is exposed to high heat.

Chemist Ron Najafi summarizes, saying “NDMA in this case…is not an impurity in the drug. It’s being formed from the drug itself,” quotes Deseret. 

CBS goes on to say that the amount of NDMA increases notably when the drug is heated up. When ranitidine is heated to 158 degrees, NDMA levels rose to 142 nanogram — well above the FDA’s daily acceptable intake limit of 96 nanogram of NDMA. Najafi notes that there are a range of seemly innocuous instances in which a drug could be heated to 158 degrees. For instance, if a patient accidentally left their medication in their car on a hot summer day, the drugs might reach 158 degrees fairly easily.

NDMA levels were seen to rise in ranitidine if it was left at room temperature for 12 day, says CBS, but much lower. After 12 days at room temperature, ranitidine’s NDMA levels reportedly increased to 25 nanograms per day. Happily, this is well below the FDA’s accepted level.

Though this new research provides valuable insight, Dr. Janet Woodcock, head of drug evaluation and research at the FDA, says there is much more to learn about ranitidine and NDMA. She says that researchers have yet to determine if the drug needs to be kept cold to prevent it from converting into NDMA. Another important piece of information that researchers do not yet have is whether or not the drug can convert into NDMA once ingested, explains CBS. 

What are the Side Effects of NDMA?

NDMA (N-Nitrosodimethylamine) has been classified as a probable human carcinogen, after testing done on animals showed that NDMA exposure may result in the development of tumors. In addition to the possible increased cancer risk related to NDMA exposure, the chemical compound may result in other health consequences.

Side effects of NDMA exposure may include jaundice, nausea, fever, abdominal cramps, vomiting, headache, fever, and dizziness. Additional long term side effects may include damage to the kidneys, lungs, and liver.

If you have consumed Zantac recalled by Sandoz, Apotex, or another pharmaceutical company and have suffered from side effects related to NDMA exposure, you may qualify to have an attorney review your case.

Join a Free Zantac Cancer Lawsuit Investigation

If you or a loved one was diagnosed with stomach cancer or bladder cancer after taking Zantac or another ranitidine medication, you may qualify to join this Zantac cancer lawsuit investigation. Learn more by filling out out the form on this page for a free case evaluation by a Zantac cancer injury lawyer.

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