Manufacturers have recently initiated Zantac recalls due to concerns that the products are contaminated with a known carcinogen.

According to the U.S. Food and Drug Administration (FDA), many pharmaceutical manufacturers have initiated recalls of their ranitidine products. Ranitidine, an anti-acid medication commonly sold under the brand name Zantac, has recently been the object of concern due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen.

On Nov. 6, Aurobine Pharma USA announced that they were recalling 38 lots of their ranitidine tablets, capsules, and syrups on the retail or consumer level. According to the FDA release, NDMA was discovered in the medications but there have not been any adverse events. A full list of affected batches is available on the FDA’s website.

On Nov. 8, American Health Packaging followed suit when they recalled 8 lots of their ranitidine syrup on a consumer level due to NDMA contamination. The recall was reportedly initiated following the recall of the same products by manufacturer Lannett Company Inc. which supplies the medication to be repackaged by American Health. A full list of affected batches is available on the FDA’s website.

On Nov. 12, Amneal Pharmaceuticals became the third company to recall ranitidine products at the beginning of November. The company reportedly recalled their ranitidine tablets and syrups due to NDMA contamination.

Zantac Recalls

On Sept. 13, the FDA announced that Zantac products had been tested and showed the presence of NDMA. NDMA is an environmental contaminant that can be found in water and foods such as meat, dairy products, and vegetables. The chemical may also be produced as a part of industrial processes.

NDMA has been classified as a probable human carcinogen. The FDA reportedly is not fully informed about the long term health consequences of NDMA in ranitidine products due to a lack of long term studies.

The FDA’s initial statement said that the amount of NDMA in Zantac was found at low levels. Based on this, the agency said that they would not be recalling any products nor recommending actions for patients.

Since their initial statement, the FDA has reportedly recommended Zantac recalls if the ranitidine product is tested and shown to contain NDMA contamination. If the NDMA levels are above the FDA’s acceptable daily intake (96 ng or 0.32 parts per million for ranitidine), the FDA has recommended a recall.

“Some companies have recalled ranitidine based on tests showing levels of NDMA above the acceptable daily intake, while some have recalled without doing testing based only on the potential for NDMA in the drug,” the FDA notes.

Even though all ranitidine products have not been recalled entirely, with only some lots affected, some pharmacies have reportedly decided to show an “abundance of caution” by removing all ranitidine from their shelves. The FDA states that this doesn’t mean the medications were recalled, but it may affect a consumer’s ability to find ranitidine products.

If consumers are concerned about taking ranitidine, the FDA recommends taking alternatives including Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).