Diabetes Drug Metformin Recalled by Multiple Manufacturers Over Carcinogens

One manufacturer of a widely-used drug to help diabetics produce insulin and help control their blood sugar recalled that drug on Wednesday because it contained levels of carcinogens higher than recommended by the federal food and drug administration.

Lupin Pharmaceuticals Inc. voluntarily recalled all 500mg and 1,000mg batches of Metformin Hydrochloride Extended Release Tablets because they contain more carcinogens than recommended by the U.S. Food and Drug Administration (FDA).

Lupin is the second company in three days to recall the drug, designed to improve glucose levels in patients with Type 2 diabetes, because of its high levels of impurities that can cause cancer.

Lupin said in a statement that certain batches of the extended-release tablets tested were above the Acceptable Daily Intake Limit of the carcinogen N-Nitrosodimethylamine (NDMA).

"Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US," the company stated. "To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall."

NDMA is classified as an impurity that could possibly cause cancer, and it's a known environmental contaminant that's also found in water and foods, including meats, vegetables and dairy products.

These are the recalled bottles with their distribution dates:

  • 500 mg bottles with NDC No. 68180-336-07 (11/05/2018 — 05/22/2020)
  • 500 mg bottles with NDC No. 68180-338-01 (11/21/2018 — 05/27/2020)
  • 1000 mg bottles with NDC No. 68180-337-07 (11/05/2018 — 05/22/2020)
  • 1000 mg bottles with NDC No. 68180-339-09 (11/21/2018 — 05/27/2020)

Lupin Pharmaceuticals said it will contact all vendors, wholesalers, distributors, drug chains, mail-order pharmacies and supermarkets to send the product back, or arrange for a return of the drug back to them.

Metformin
500mh Metformin tablets. Francis Dean/Corbis/Getty

Metformin Hydrochloride Extended Release Tablets are prescribed by doctors to help adults with Type 2 diabetes improve their blood glucose levels with the aid of exercise and diet.

The FDA advises that patients who are currently taking the drug to keep taking it until their doctors move them to an alternative treatment.

"It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals," the FDA stated.

Lupin isn't the only company to recall Metformin this week, and they're the sixth company in all to do it. On Monday, Granules Pharmaceuticals recalled 12 different 750mg batches of Metformin Hydrochloride Extended Release Tablets, just because one batch of it tested positive for NDMA levels higher than allowed by the FDA.

Walmart is one of the big box retailers that carry the Granules Metformin, and Walmart issued the recall on its website this week, according to the Miami Herald. Among those recalls (all 100-count bottles) are:

  • No. 4920003A (Exp. May 2021)
  • No. 4920004A and No. 4920005A (Exp. June 2021)
  • No. 4920009A (Exp. Nov 2021)
  • No. 4920010A (Exp. May 2022)
  • No. 4920011A and 224920012A (Exp. June 2022)
  • No. 4920013A and 4920014A (Exp. July 2022)
  • No. 4920015A (Exp. August 2022)
  • No. 4920016A (Exp. January 2023)