Nizatidine Recall Due to NDMA

Nizatidine Recall Nationwide

On January 8, 2020, the U.S based Mylan Pharmaceuticals has conducted a voluntary nationwide Nizatidine recall on three lots of Nizatidine capsules (including strengths of 150mg and 300mg) due to trace amounts of N-Nitrosodimethylamine detected in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited. The three recalled lots were distributed between June 2017 and August 2018. As of today January 9, 2020, there are no lawsuits filed against Mylan. Lots included in the Nizatidine recall: Nizatidine Capsules, USP 150mg (60) lot 3086746, Nizatidine Capsules, USP 300mg (30) lot 3082876, and Nizatidine Capsules, USP 300mg (30) lot 3082877.

What is Nizatidine?

Nizatidine is an antacid that can be used as a short-term treatment of active duodenal ulcers and active gastric ulcers. It can also be used to treat certain stomach and throat problems (like erosive esophagitis, gastroesophageal reflux disease-GERD).


What is N-Nitrosodimethylamine?

N-Nitrosodimethylamine which is also known as NDMA is very harmful to the liver of animals and humans. NDMA is classified as a B2 carcinogen meaning it is known to cause cancer to animals and is a probable cause of cancer in humans.  Trace amounts can be found in certain foods but are believed to not be harmful. The FDA will only allow up to 96 nanograms in drugs meant for human consumption.

Nizatidine vs Zantac

A number of Zantac lawsuits have been filed following a recent FDA recall of Zantac due to a finding of 3,000,000 nanograms of NDMA in some lots of Zantac. The amount of NDMA discovered in the above Nizatidine lots have not been disclosed at this time.

Injuries Associated with NDMA

The link between NDMA and cancer is being investigated for the following types of cancers: cancer of the stomach, esophagus, kidney, liver, bladder, intestinal cancer, testicular cancer, pancreatic cancer, colorectal cancer, uterine cancer, and ovarian cancer.

If you have taken Nizatidine for 3 months prior to any of the diagnoses above, then you may have a claim for compensation. You can contact Simmons and Fletcher, P.C. for further information.