Mylan Recalls 3 Lots of Nizatidine Capsules Due to Impurity

No adverse reports have been received related to these batches to date, according to the company.

A voluntary nationwide recall has been announced by Mylan Pharmaceuticals for 3 lots of nizatidine capsules, USP. The capsules are being recalled due to detected trace amounts of impurity N-nitrosodimethylamine (NDMA) contained in the active pharmaceutical ingredient (API) nizatidine, USP.

No adverse reports have been received related to these batches to date, according to the company.

NDMA is a contaminant found in water and foods, including meats, dairy products, and vegetables. The impurity is classified as a probable human carcinogen, according to the International Agency for Research on Cancer.

Nizatidine is indicated for the short-term treatment of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to 1 year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease.

The batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018. The batches include lot number 3086746, which expires May 2020; and lot numbers 3082876, and 3082877, both of which expire January 2020.

Consumers should contact their physician or health care provider if they have experienced any problems in relation to using these drug products, according to Mylan.


  • FDA Vows to Uphold Drug Quality Standards in Response to Recent Impurity Concerns
  • Amneal Recalls Ranitidine Products Due to Potential NDMA Impurity


Mylan initiates voluntary nationwide recall of three lots of nizatidine capsules, USP, due to the detection of trace amounts of NDMA (n-nitrosodimethylamine) impurity found in the active pharmaceutical ingredient manufactured by solara active pharma scien [news release]. Hertfordshire, England, and Pittsburgh, PA; January 8, 2020: Mylan. Accessed January 8, 2020.