Why Was Metformin Recalled in 2020?

Metformin is a generic prescription drug used to lower blood sugar in people with type 2 diabetes. Drug manufacturers also sell Metformin products under other names, including brand name Glucophage. In December 2019, the U.S. Food and Drug Administration (FDA) launched its first investigation into Metformin after learning that health officials in other countries had recalled lots of Metformin hydrochloride extended-release tablets over concerns that the diabetes drug contained unsafe levels of NDMA. This is the standard abbreviation for n-nitrosodimethylamine.

Although some foods, consumer products, and certain medications contain low levels of NDMA, some lots of Metformin hydrochloride exceeded the FDA maximum recommendation of 96 nanograms per day. The reason for this is that high levels of NDMA acts as a contaminant in the human body and can cause adverse events, including cancer. In fact, the FDA labeled the NDMA in affected lots of Metformin hydrochloride as a probable human carcinogen in May 2020. This came after an initial announcement in February 2020 stating that it did not find high levels of NDMA in its first study.

Manufacturers Involved in the Metformin Recall

In June 2020, the FDA announced in a press release that five drug manufacturers agreed to a voluntary recall of their extended-release Metformin products due to an impurity that caused high levels of NDMA. These drug manufacturers include:

  • Amneal Pharmaceuticals
  • Apotex Corporation
  • Granules Pharmaceuticals
  • Lupin Pharmaceuticals
  • Marksans Pharma Limited
  • Teva Pharmaceuticals

Bayshore Pharmaceuticals issued a voluntary recall in August 2020. The Metformin recall also included drug companies that package and sell Metformin under the direction of one of the above pharmaceutical companies. Drug repackagers involved in the voluntary recall include:

  • Avkare Inc. and PD-Rx under Amneal Pharmaceuticals
  • Harvard Drug Group under Apotex Corporation
  • Preferred Pharmaceuticals under Marksans Pharma Limited

In its most recent press release dated October 5, 2020, the FDA announced that Marksans Pharma Limited expanded its voluntary Metformin recall to include 76 lots of Metformin tablets with a label from Time-Cap Labs. Sun Pharmaceuticals is the most recent drug manufacturer to  join the voluntary Metformin recall by recalling one lot of Metformin hydrochloride.

If you have cancer and think you may have developed it after takings Metformin extended-release tablets with an NDMA impurity, we encourage you to check the FDA List of Recalled Metformin Products. You need to know the National Drug Code (NDC) number, which you can find at the U.S. Food and Drug Administration National Drug Code Directory. The other number you need is the drug’s lot number, typically located on its packaging.

How Did Some Lots of Metformin Have NDMA Contamination?

Prescription drugs can become contaminated during the manufacturing process for a variety of reasons. Here are some of the most common issues that can lead to a prescription drug having levels of NDMA considered too high by the FDA:

  • Manufacturing process defect: The way scientists form NDMA makes a difference. Certain types of amine molecules should not be near nitrite molecules. When these molecules combine, it can create contaminated NDMA.
  • Cross-contamination of fluids used in manufacturing process: Drug manufacturers use expensive fluids to make several different types of drugs. Because of the cost, they often try to recover unused fluids from the production of one drug and use it when creating the next batch of drugs. If the fluid contains NDMA, it can transfer to the next batch and become contaminated.
  • Cross-contamination of manufacturing equipment: If a scientist prepares one type of medication on a machine and does not thoroughly clean it, NDMA can remain on the machine and make it into the next batch of drugs. Cross-contamination still occurs despite the rigorous cleaning standards of drug manufacturers.

In the case of Metformin ER, it appears the NDMA broke down when drug manufacturers stored the capsules at temperatures exceeding normal room temperatures. The FDA conducts periodic reviews of drugs after they have gained approval to check for impurities and other problems. In this case, however, it was governments outside of the United States that first became aware of the problem.

What to Do if You Currently Take Metformin ER (Extended-Release) Capsules

If you currently take this diabetes drug and feel concerned about possible high levels of NDMA, speak to your healthcare provider about alternative treatment options for your type 2 diabetes. You should not abruptly stop taking Metformin ER on your own without first speaking to health care professionals. You could experience a dramatic shift in your blood sugar numbers if you stop taking Metformin ER suddenly, which could in turn cause serious health complications.

Are You Eligible to File a Defective Drug Lawsuit?

Consuming products with high levels of NDMA for an extended time can increase your risk of developing cancer. The following types of cancer are most associated with NDMA:

  • Bladder
  • Colorectal
  • Esophageal
  • Intestinal
  • Kidney
  • Leukemia
  • Liver
  • Non-Hodgkin’s lymphoma
  • Pancreatic
  • Prostate
  • Stomach

Keep in mind this is not an all-inclusive list of the types of cancer caused by high levels of NDMA. NDMA can also damage internal organs even if it does not cause cancer, especially the liver. We urge you to schedule an appointment with your healthcare provider if you develop any new or persistent symptoms. Health care professionals must diagnose you with cancer or another illness and your attorney must be able to prove a conclusive link with high levels of NDMA before you can file a lawsuit. This includes joining other patients harmed by Metformin products in a class-action lawsuit.