Numerous recalls have been issued for the diabetes drug metformin after tests found high levels of a cancer-causing chemical called NDMA.for Toxic NDMA Carcinogens
In September 2020, Sun Pharma recalled one lot of Riomet ER® (metformin) due to high levels of NDMA. The product is a liquid that is packaged in a 16-oz. round bottle. The recall involves Riomet ER (500 mg per 5 mL), with Lot Number AB06381 and Expiration Date 10/2021.
List of Metformin Recalls for High Levels of NDMA Carcinogens
On January 25, 2021, Nostrum Laboratories expanded a metformin ER recall for a 2nd time after finding high levels of NDMA inMetformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) with Lot MET200601 and an expiration date of 07/2022.
On January 4, 2021, Nostrum Laboratories expanded a recall issued on November 2 to also include Lot #MET200501 of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) due to high levels of NDMA. It is an off-white oblong tablet debossed with “NM7.”
On November 2, 2020, Nostrum Laboratories recalled Metformin Extended Release (750-mg) due to high levels of NDMA carcinogens. The recall involves 2 lots (MET200101 and MET200301) with expiration dates of 05/2022. They were packaged in bottles of 100 tablets.
On October 2, 2020, Marksans Pharma Ltd. expanded a metformin recall due to detection of NDMA carcinogens. The recall involves 76 lots of Metformin ER in 500-mg and 700-mg dosages. It was distributed by Time-Cap Labs Inc., in bottles containing 90, 100, 500, or 1000 pills.
On August 21, 2020, Bayshore Pharmaceuticals of New Jersey recalled one lot of 500-mg and one lot of 750-mg Metformin Extended-Release after FDA tests found high levels of NDMA.
On July 8, 2020, Lupin Pharmaceuticals Inc. recalled all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg due to NDMA. The products were distributed between November 2018 and May 2020.
On July 3, 2020, Granules Pharmaceuticals recalled 12 lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 due to NDMA.
On June 11, 2020, Lupin Pharmaceuticals, Inc. recalled one lot of Metformin Extended-Release (generic equivalent of Fortamet®), 500mg, Lot G901203 due to unsafe levels of NDMA.
On June 5, 2020, Marksans Pharma Limited, India recalled 1 lot of Metformin Extended-Release (Metformin ER) due to NDMA contamination. The recall involves metformin ER (500-mg) — Lot# XP9004 — in 100 count bottles with NDC code 49483-623-01 and expiration date 12/2020. It was distributed by Time-Cap Labs, Inc.
On June 5, 2020, Teva Pharmaceuticals recalled 14 lots of Metformin Extended-Release (500-mg and 750-mg) due to unsafe levels of NDMA. The recall involves Actavis® Metformin ER that was distributed between January 8, 2019 and May 27, 2020.
On May 29, 2020, Amneal Pharmaceuticals recalled all lots of Metformin Extended-Release (500-mg and 750-mg) due to high levels of a carcinogenic chemical called NDMA. According to Valisure, one lot of metformin ER had 16.5-times the FDA’s daily limit of NDMA.
On May 27, 2020, Apotex Corp. recalled all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg due to high levels of the carcinogenic chemical NDMA (N-Nitrosodimethylamine). Apotex stopped selling this product in the U.S. in February 2019. The product was sold in 100-count bottles with NDC Number 60505-0260-1.
FDA Tests Find High Levels of NDMA
In May 2020, the FDA contacted 5 drug-makers after testing found unsafe levels of NDMA carcinogens in several batches of extended-release metformin, according to Bloomberg.
Immediate-release metformin was not contaminated with dangerous levels of NDMA, according to the FDA.
The next step may be recalls from drug-makers — and potentially, a flood of metformin lawsuits involving people with cancer.
The FDA announcement is a major reversal. In February, the FDA said its initial tests did not find high levels of NDMA in metformin. Those findings were challenged by Valisure, the same pharmacy that found NDMA in blood pressure drugs and prompted dozens of recalls and lawsuits.
Valisure Pharmacy Demands Metformin Recalls for High Levels of NDMA Contamination
In March 2020, the online pharmacy Valisure recommended that the FDA recall 16 batches of metformin made by 11 different companies due to excessive levels of NDMA contamination. Several batches had over 10X the daily intake limit for NDMA. The highest amount of NDMA was found in a batch of metformin made by Amneal Pharmaceuticals LLC, which contained 16.5X the daily limit of NDMA. Valisure said there was significant variability from batch to batch, even from the same company.
Valisure’s Tests Find NDMA in Metformin — FDA’s Tests Did Not
It is not clear why Valisure’s tests on metformin found high levels of NDMA when the FDA’s tests found no NDMA or extremely low levels. Valisure tested far more batches of metformin than the FDA and used a more accurate testing method. Valisure tested 38 batches made by 22 companies, with 42% testing positive for levels of NDMA above the FDA’s daily acceptable intake limit of 96-ng per day. The FDA only tested 16 batches of metformin from 7 companies.
Are There Cancer-Causing Chemicals in Metformin?
After 3 batches of metformin were recalled in Singapore in 2019, the FDA began investigating whether metformin in the U.S. contained the same carcinogen (NDMA) that led to dozens of recalls for blood-pressure drugs (valsartan) and heartburn medications (Zantac). In Febraury 2020, FDA said its tests did not find excessive levels of NDMA — but their results are being questioned.
FDA Find No NDMA or Very Low Levels in Metformin
On February 3, 2020, the FDA issued a statement to report that extensive laboratory tests on metformin did not find high levels of n-nitrosodimethylamine (NDMA). The tests found either no detectable levels of NDMA, or levels that were too low to require a recall: “To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.”
FDA Investigating Cancer-Causing Toxins in Metformin
In December 2019, the FDA issued a Safety Alert after metformin was recalled in other countries due to NDMA contamination. The FDA is investigating whether metformin sold in the U.S. contains NDMA, and if it does, whether it is above their acceptable daily limit. If so, the FDA said it will recommend recalls.
What is NDMA?
N-Nitrosodimethylamine (NDMA) and similar chemicals, known collectively as nitrosamines, are toxic chemicals that are known to cause cancer in humans. NDMA is a common contaminant in water and some foods, such as grilled meat, dairy products, and vegetables.
Cancer Risk is Especially Serious for “Lifetime” Drugs Like Metformin
Unfortunately, NDMA contamination is especially concerning for a diabetes drug like metformin, because patients must take multiple pills of metformin every day for the rest of their lives. Exposure to carcinogenic chemicals every day for decades could significantly increase a person’s risk of developing cancer.
What Types of Cancer Does NDMA Cause?
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Esophageal cancer
- Ovarian cancer
- Testicular cancer
- Bladder cancer
- And more
Metformin Recalls in Singapore
Metformin has not been recalled in the U.S. However, outside the U.S., 3 types of metformin were recalled in Singapore after tests found unacceptable levels of NDMA.
Metformin Recalls in Canada
In February 2020, multiple metformin recalls were issued in Canada due to NDMA contamination above the daily acceptable limit. On February 5, Apotex recalled certain lots of Metformin ER (extended release) 500 mg tablets in Canada. On February 26, Ranbaxy Pharmaceuticals recalled 6 lots of metformin from the Canadian market.
After Recalls, Multiple Countries Test Metformin for NDMA
Investigations are currently underway in the U.S., Canada, the European Union and the U.K. to determine if metformin sold in those countries also contains NDMA.
What is Metformin?
Metformin is the 4th-most-commonly prescribed drug in the U.S., with approximately 80 million prescriptions written in 2019. It is a prescription drug that is used to control high blood-sugar levels in people with type-2 diabetes. Metformin is a generic medication that is sold under the names Fortamet, Glucophage, Glumetza, and Riomet.
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