A generic form of the drug Zantac has been subjected to recall over concerns that it could be contaminated with a carcinogen.

Ranitidine hydrochloride is the generic name for Zantac, a heartburn medication. On October 25, 2019 the drug’s maker, Novitium Pharma, issued a voluntary recall of the drug. The affected forms of ranitidine include 150 mg and 300 mg capsules, says the FDA.

According to the company, the drugs may be contaminated with n-nitrosdimethylamine (NDMA), a chemical characterized by the FDA as a “probable human carcinogen.” The FDA reports that the ranitidine was found to be contaminated with NDMA after laboratory tests.

The recall was issued voluntarily by Novitium Pharma Inc., the makers of the drug. The recall was issued in an effort to protect consumers from possible health effects associated with NDMA. The recall reportedly affects all quantities and lots of the drug that are within their expiration date.

About Zantac

Zantac is a histamine-2 blocker. It works to prevent heartburn by reducing the amount of acid in the stomach. Zantac also treats a number of conditions linked to heartburn, including ulcers, Zollinger-Ellison syndrome, and gastroesophageal reflux disease.

Like many drugs, Zantac does have some side effects. Drugs.com reports that the medication can increase a patient’s risk of pneumonia, and may not be safe for use in patients with kidney or liver disease.

About NDMA

NDMA is a carcinogen that can be found in some water and foods. The FDA explains that it is found in low levels in some meat products, dairy, and vegetables. Though NDMA is found in some products we do consume, the presence of NDMA can be concerning in higher amounts.

On November 1, the FDA released a statement about the issue of possibly contaminated ranitidine. The FDA is currently investigating possible contamination of the drugs. The FDA reports that levels of NDMA present in ranitidine is similar to those levels found in common foods like grilled or smoked meats.

According to the FDA, the levels that the agency found are lower than those reported by third-party testers. However, the FDA does state that some levels are higher than those considered to be acceptable. As a result, the FDA has requested that ranitidine makers recall the drug. The manufactures have also been asked to send samples of their drugs to the FDA for testing. 

The FDA states that the agency is still investigating the issue, in an effort to fully understand why ranitidine might be contaminated.

Unfortunately, Zantac is not the only drug that has possibly been contaminated with NDMA recently. In 2018, the contaminant was found in a number of blood pressure medications. These medications involved some ARB blockers including valsartan. This led to recalls like the ranitidine recall.

In the case of the Valsartan recall, the drugs were reported to be contaminated during a manufacturing process. Reportedly, in some cases of the possible NDMA contamination, NDMA was produced as an accidental byproduct of some manufacturing processes after factories changed their manufacturing procedures for the drugs.