FDA Recalls Metformin After Finding Known Carcinogen

The FDA continues to recommend manufacturer recalls of the popular diabetes medication metformin after testing shows the presence of a known carcinogen, N-nitrosodimethylamine, more commonly known as NDMA. On October 5, 2020, the FDA alerted patients and health care professionals of two new metformin recalls for products manufactured by Marksans Pharma and Sun Pharmaceutical for NDMA contamination.

Metformin is only available by prescription and is used to control high blood sugar in patients with type 2 diabetes. To date, all recalls apply to the extended-release versions of the metformin medication.

NDMA seems to be popping up everywhere these days. In the past 2 years, several drugs including angiotensin II receptor blockers (ARBs), such as valsartan, and ranitidine, commonly known as Zantac, have been found to contain NDMA.

How did metformin become contaminated with NDMA?

The FDA is still investigating how the NDMA ended up in certain lots of metformin. In some instances, like valsartan, NDMA enters the medication through contamination during the manufacturing process. For Zantac and ranitidine, NDMA is created either as a byproduct of the medication as it metabolizes in the body, or by how the ingredients react within the medication itself.

The FDA began testing metformin for NDMA in December 2019 after being alerted to recalls of the drug in other countries. On May 28, 2020, the FDA announced that agency lab testing revealed levels of NDMA above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation. The FDA contacted the metformin manufacturers to recommend they voluntarily recall their products. The initial round of recalls involved 5 companies.

  • Amneal Pharmaceuticals
  • Marksans Pharma
  • Teva Pharmaceuticals
  • Apotex Corp
  • Lupin Pharmaceuticals

Since that time additional recalls have extended the list of companies to include three more metformin manufacturers:

  • Granules Pharmaceuticals
  • Bayshort Pharmaceuticals
  • Sun Pharmaceutical

The FDA’s official website provides an extensive list of metformin recalls with lot numbers and NDC codes.

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