Class Action Lawsuits Filed Over Metformin NDMA Contamination

The makers of generic versions of metformin face a growing number of class action lawsuits, following allegations that some batches contain high levels of the cancer-causing chemical byproduct N-nitrosodimethylamine (NDMA), which has been linked to reports of stomach cancer, colorectal cancer and other injuries after contaminating other drugs.

In recent days, at least two new class action claims have been filed. One complaint (PDF) was filed by Jacqueline Harris in New Jersey federal court on March 27, and the other compaint (PDF) was filed by Michael Hann on March 30 in the same court.

Both see class action status for all consumers who purchased metformin contaminated with NDMA. According to the complaints, the drug makers named as defendants misrepresented the safety of metformin for years, and knew or should have known about the presence of NDMA. Harris’s lawsuit names Aurobindo, Aurolife Pharma, Heritage Pharmaceuticals, Emcure Pharmaceuticals, Rite-Aid Corporation and potentially dozens of unnamed parties as defendants. Hann’s lawsuit names Heritage Pharmaceuticals as the defendant.

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NDMA is a chemical byproduct considered a carcinogen. In recent months, detection of the chemical in other drugs has resulted in wide scale Zantac recalls and valsartan recalls, after it was confirmed that dangerously high levels of NDMA were present in the popular heartburn and blood pressure medications.

Late last year, reports first warned about the potential risk of metformin NDMA contamination problems, after some versions of the drug sold outside the United States tested positive for the chemical, raising concerns that metformin recalls may be necessary. However, the FDA indicated at that time that testing of products distributed in the U.S. found that the NDMA levels in metformin were undetectable or below federal limits for exposure to the chemical.

Earlier this month, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to issue metformin recalls, after independent testing found levels of NDMA in certain pills that was higher than the agency’s recommended daily exposure threshold of 96 nanograms.

Metformin is sold by a number of different generic drug makers, and also marketed under several brand names, including Glucophage, Carbophage, Fortamet, Diabex and Riomet. It is also often used in combination with other diabetes drugs.

“At all times during the period alleged herein, Defendants represented and warranted to consumers that their generic Metformin products were otherwise fit for their ordinary uses, and were otherwise manufactured and distributed in accordance with applicable laws and regulations,” Harris’s lawsuit states. “However, for years, Defendants willfully flouted federal current Good Manufacturing Practices and ignored other warnings signs that Defendants’ Metformin products contained or likely contained NDMA and/or other impurities.”

NDMA In Zantac and Valsartan

Valisure is the same pharmacy which first raised alarms about the link between Zantac and cancer in September 2019, after finding that some pills contained 3,000,000 ng of NDMA. This led to further FDA testing, which confirmed the high levels were present in virtually all Zantac products and their generic equivalents, resulting in a widespread, and still ongoing, Zantac recall.

Concerns over NDMA drug contamination in pharmaceutical drugs began to emerge in 2018, with an investigation into a number of generic blood pressure drugs that were found to contain high levels of the chemical. This led to several rounds of recalls for valsartan, losartan and irbesartan, and investigations suggested that NDMC may have contaminated the drugs as a by-product of changes in the generic drug manufacturing process.

In response to concerns about the cancer risk with valsartan and other similar drugs, and the possibility of shortages for the hypertension drugs, the FDA established a permissible daily limit for NDMA at 96 nanograms, requiring pills that may expose users to more of the carcinogen to be recalled.

While drug makers and federal regulators indicate they are continuing to investigate the underlying cause of both the NDMA contamination, many consumers diagnosed with cancer in recent years are now pursuing valsartan lawsuits and Zantac lawsuits, alleging they may have avoided a cancer diagnosis if other treatments had been used.

29 Comments

  • dougApril 28, 2024 at 9:46 pm

    ihave been taking metformin for 22 years and now i have been told that i have cancer in my bladder and my right kidney

  • PatriciaApril 16, 2024 at 5:08 am

    I have been on metformin for years, now I have stage 4 kidney disease

  • ConnieFebruary 18, 2024 at 10:11 pm

    Nov 2022 Metformin caused me to be very ill, had memory loss for at least one week, they, the Drs fought hard to keep me alive, the Dr set on my bed and said I should be dead, thats how serious the illness was. Now I had been on Metformin for at least 10 years and probable much more time. and all of a sudden, I'm fighting for my life. I still have problems saying words that I should know, "brain f[Show More]Nov 2022 Metformin caused me to be very ill, had memory loss for at least one week, they, the Drs fought hard to keep me alive, the Dr set on my bed and said I should be dead, thats how serious the illness was. Now I had been on Metformin for at least 10 years and probable much more time. and all of a sudden, I'm fighting for my life. I still have problems saying words that I should know, "brain fog", they say the severe foot pain I have is caused by Metformin, cancer of the kidney, I didnt even know my husband and we have been married 52 years, that just makes me so mad, two Dr. listed the cause was Metformin. Please, Please help me- I finally found you tonight after trying for over a year- contacted attorney around hear but was told need to find one that handle's these cases. If you no longer handle these lawsuit please give me a name of someone who does, I need your help

  • ConnieFebruary 15, 2024 at 8:58 pm

    Nov 2022 Metformin caused me to be very ill, had memory loss for at least one week, they, the Drs fought hard to keep me alive, the Dr set on my bed and said I should be dead, thats how serious the illness was. Now I had been on Metformin for at least 10 years and probable much more time. and all of a sudden, I'm fighting for my life. I still have problems saying words that I should know, "brain f[Show More]Nov 2022 Metformin caused me to be very ill, had memory loss for at least one week, they, the Drs fought hard to keep me alive, the Dr set on my bed and said I should be dead, thats how serious the illness was. Now I had been on Metformin for at least 10 years and probable much more time. and all of a sudden, I'm fighting for my life. I still have problems saying words that I should know, "brain fog", they say the severe foot pain I have is caused by Metformin, cancer of the kidney, I didnt even know my husband and we have been married 52 years, that just makes me so mad, two Dr. listed the cause was Metformin. Please, Please help me- I finally found you tonight after trying for over a year- contacted attorney around hear but was told need to find one that handle's these cases. If you no longer handle these lawsuit please give me a name of someone who does, I need your help

  • JamesJanuary 11, 2024 at 3:31 pm

    I am taken metformin I have trouble with my stomach and legs I have a new docotor and he put me on it but back in 2018 my old doctor took me off and I had to have triple by pass sergury because of it and now i also have some memory loss. What are my actions now is there a law suit?

  • johnnieAugust 1, 2023 at 8:46 am

    The doctor prescribed metformin in 2009, I have had issues with my stomach and kidneys ever since. I recently in 2020 notice there was a recall for metformin and spoke to the doctor about the recall. He informed me that I had nothing to worry about that metformin was still okay to take. Now I have heart valve issues, constant cramping in my legs and I am concerned that taking this drug has caused[Show More]The doctor prescribed metformin in 2009, I have had issues with my stomach and kidneys ever since. I recently in 2020 notice there was a recall for metformin and spoke to the doctor about the recall. He informed me that I had nothing to worry about that metformin was still okay to take. Now I have heart valve issues, constant cramping in my legs and I am concerned that taking this drug has caused multiple issues with my health.

  • SandiJanuary 11, 2023 at 4:26 pm

    I lost my husband in 2018. He was diabetic & took metformin. What are my actions to take at this time for the lawsuit?

  • connieOctober 3, 2022 at 10:26 pm

    i took metformin for years when i first had diabetes.when my dr. took me off of them i discovered i had kidney disease.

  • DominicAugust 9, 2022 at 5:24 pm

    I've read the comments from those on Metformin and I'm saying, how familiar these reactions to metformin we share. Makes me so angry, we've been blind sided again by the institutions who are only, money hungry. I'm told that there is a definite connection with eye care issues which often result in, so called surgerie$surgeries. Again, hungry for the big buck$. I've got to get ahold on law firms w[Show More]I've read the comments from those on Metformin and I'm saying, how familiar these reactions to metformin we share. Makes me so angry, we've been blind sided again by the institutions who are only, money hungry. I'm told that there is a definite connection with eye care issues which often result in, so called surgerie$surgeries. Again, hungry for the big buck$. I've got to get ahold on law firms who will $ue for clients who have been taken advantage of for many, many years.

  • janetApril 14, 2022 at 2:18 pm

    Took Metformin for years, now in kidney failure. Colon cancer 5 years ago. On dialysis 3 days a week.

  • LupeJanuary 28, 2022 at 1:28 pm

    My mother has kidney disease due to taking Metformin. Her health has gone downhill since. It’s heartbreaking seeing her the way she has ended up because of this medication.

  • JacquelynDecember 10, 2021 at 10:29 am

    My husband has been taking metformin for over 20 years and now he is a risk of kidney failure. On December 1, we discovered his kidney has decreased to 38% , we had no idea about this medication after not being able to control his blood sugar this weekend he was taken to the hospital and was taken off of metformin, now we have to deal with his kidney problems.

  • SidneyNovember 25, 2021 at 3:33 pm

    I was prescribed Metformin HCL 500 MG daily and I have all these side effects. Unusual muscle pain feeling cold trouble breathing weak all the time stomach pain constipation diarrhea

  • GriseSeptember 15, 2021 at 4:33 am

    My mother took Metformin for over 15 years. She now has stage 5 renal disease. My family and I believe this disease was caused from taking Metformin for so many years. Some years ago she was informed by her doctor to stop taking Metformin because it was recalled. I am upset and angry that her demise will be due to a medication that was supposed to help her. I've provided my email. Does my mother h[Show More]My mother took Metformin for over 15 years. She now has stage 5 renal disease. My family and I believe this disease was caused from taking Metformin for so many years. Some years ago she was informed by her doctor to stop taking Metformin because it was recalled. I am upset and angry that her demise will be due to a medication that was supposed to help her. I've provided my email. Does my mother have a case?

  • SherryAugust 7, 2021 at 5:49 pm

    My husband was a diabetic who took Metformin 500mg twice daily starting in 2000. Around 2007 the dr. increased it to 750 mg twice daily and finally he was taking 1000mg twice daily. In 2008 he was diagnosed with prostate cancer. It was treated with chemotherapy and direct beam radiaton. In 2017 he was diagnosed with colorectal cancer and died from that cancer in 2018. There was no autopsy so how w[Show More]My husband was a diabetic who took Metformin 500mg twice daily starting in 2000. Around 2007 the dr. increased it to 750 mg twice daily and finally he was taking 1000mg twice daily. In 2008 he was diagnosed with prostate cancer. It was treated with chemotherapy and direct beam radiaton. In 2017 he was diagnosed with colorectal cancer and died from that cancer in 2018. There was no autopsy so how would I know if his cancers were a result of taking contaminated Metformin?

  • DanJuly 16, 2021 at 10:22 pm

    I toook metformin for years, along with zantac. Stage 3 colon cancer. No family history.

  • KennethMay 20, 2021 at 5:51 pm

    I was on Metformin 1000mg twice a day. I now have stage 4 kidney cancer that has spread to both lungs, I have recently been taken off Metformin. I as now receiving infusions for the cancer.

  • DebraApril 2, 2021 at 6:11 am

    I was on Metformin 1000mg twice a day for several years. I ended up in the hospital due to very high blood pressure and was diagnosed with lactic acidosis. They took me completely off the Metformin then determined I had stage 4 kidney disease. I now live with kidney disease and am off all diabetic medications.

  • LuciaFebruary 25, 2021 at 11:16 pm

    I have even taking Metformin 750 for the past 5 years I know broken out into these horrific rashes all over ny arms, neck, legs and feet. If I could attach a poc I would my insides are full of inflation. And Dermatologist digoisnes is Granuloma Annular and there's is nothing they can do they tell me Metformin caused this

  • SusanFebruary 24, 2021 at 10:33 pm

    My Mother died unexpectedly in her sleep at 65. We have no idea how she died, but was on Metformin for years. I suspect Metformin had something to do with it.

  • TheresaJanuary 14, 2021 at 9:55 pm

    Hi my Mother was prescribed Metformin in 2015 and passed away May 2016 from stomach cancer.

  • LaquinaJanuary 8, 2021 at 5:29 am

    I experienced a cyst inside my breast, my hair has broken out , I'm problems with my left leg since I've been on metformin 1000 mg and I take twice a day.

  • DavidOctober 20, 2020 at 4:40 pm

    I took metformin and now am in stage 3 kidney failure.

  • VirginiaOctober 10, 2020 at 12:10 am

    My husband died in 2018 from Prostate cancer. He was taking the medication Metformin for years. How do I file a lawsuit against the company who made Metformin?

  • IsaacOctober 8, 2020 at 7:45 am

    My mom passed away from liver cancer. Was very rapid and she was taking metformin for years. I have a bottle by Aurobindo Pharma dated from 2012. She’s dead now and I am looking into her records. I’m positive this caused my mother’s cancer. This is upsetting.

  • RussellJuly 16, 2020 at 8:45 pm

    I had triple bypass surgery in 2008 and was subscribed metformin 500 mg in May 2020 I have been noticing some pain in my heart when the increase of exercise I am going to schedule an appointment with the VA can NDMA effect the heart? How do we file a lawsuit ?

  • TiffanyJuly 16, 2020 at 4:46 am

    I was prescribed Metformin 750mg for my insulin resistance and had many bad side effects including a trip to the Er. I’m now having to see a pulmonary and heart doctor for symptoms that won’t go away after stopping this horrible drug.

  • AngelaJuly 9, 2020 at 6:48 pm

    I have problems with my digestive system

  • RobinJune 19, 2020 at 12:07 am

    I have been taking Metformin ER 500 mg for the past 4 to 5 years. I Recently had a cat scan That show a spot on my pancreas. 2years ago I had a catscan which was clear. I go in tomorrow to have a biopsy on the spot/cyst on the pancreas. I am very concerned now that the metformin I have been taken has been recalled. Both manufacturers! Do I or would I have grounds for a lawsuit?

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