Metformin Recall Issued Over NDMA Impurity

The latest in a string of drug recalls issued in connection with the cancer-causing substance N-nitrosodimethylamine (NDMA) is metformin, a generic diabetes drug used to treat high blood sugar levels in patients with type 2 diabetes. The metformin recall announced by the FDA last week affects Metformin Hydrochloride Extended-Release Tablets manufactured in Bangladesh and sold in the United States by Bayshore Pharmaceuticals. If you or a loved one has suffered harm allegedly caused by recalled metformin pills contaminated with NDMA, a known carcinogen, contact an experienced drug injury attorney as soon as possible to discuss your legal options. The metformin NDMA litigation is still in its early stages and you and your loved ones may be eligible for compensation through a metformin cancer claim, so don’t hesitate to call.

NDMA Contamination in Popular Medications

The FDA has been investigating NDMA and other potentially toxic nitrosamine impurities in a variety of pharmaceutical drug products since 2018, when it was discovered that generic valsartan pills manufactured in China and India and sold in the United States contained unexpectedly high levels of the carcinogenic substances. Since that time, NDMA and other cancer-causing impurities have been found in a number of other widely used medications, including the angiotensin II receptor blockers losartan and irbesartan and the heartburn drug Zantac (ranitidine). The potential contamination of ranitidine products with NDMA became such a major public health concern that the FDA in April 2020 called for all prescription and over-the-counter ranitidine (Zantac) products to be removed from the market immediately. Since becoming aware in late 2019 that metformin pills may also be tainted with NDMA, the FDA has recommended recalls of certain metformin drug products that have been found to contain levels of NDMA above the daily intake limit the FDA considers acceptable.

Metformin Recalls Issued Over NDMA Contamination

In March 2020, an independent pharmacy called Valisure – the same pharmacy that first detected NDMA in samples of Zantac – identified high levels of NDMA in certain lots of the diabetes drug metformin. The pharmacy tested 38 batches of metformin from 22 distributors and found that 16 lots from 11 companies contained levels of NDMA above the FDA’s acceptable limit. According to Valisure, several of the lots contained more than 10 times the level the FDA considers to be “safe.” Based on its findings, Valisure filed a citizen’s petition with the FDA calling for the agency to recall the affected lots of metformin and take other actions to warn the public and make the drugs safer. On May 28, 2020, the FDA issued a press release notifying patients and healthcare professionals about the presence of NDMA in certain metformin ER products. The FDA noted that it had contacted five companies to recommend that they recall the contaminated metformin drugs.

This latest metformin recall was announced after high levels of NDMA were detected in 500 mg and 750 mg Metformin Hydrochloride Extended-Release (ER) Tablets manufactured by Beximco Pharmaceuticals Limited in Bangladesh, for distribution in the United States by Bayshore Pharmaceuticals. According to the recall announcement, Bayshore was notified by the FDA that one lot of metformin ER 750 mg was tested and found to contain NDMA levels in excess of the acceptable daily intake limit and was advised to recall the tested lot. Bayshore then tested samples from eight lots of metformin manufactured using the same active pharmaceutical ingredient lot as the tainted lot and found high levels of NDMA in one lot of metformin ER 750 mg and one lot of metformin ER 500 mg. The two lots of metformin affected by the recall are lot numbers 18641 and 18657.

Pursuing Compensation for Cancer Diagnoses Allegedly Linked to Metformin

For more than a decade, metformin has been considered the first-choice medication for the long-term management of type 2 diabetes, a condition that occurs when the body doesn’t use insulin properly. Metformin ER, also known by the brand names Fortamet, Glumetza or Glucophage, is the extended release version of metformin, which means the medication lasts longer and doesn’t have to be taken as frequently as regular metformin. Otherwise, the two medications are the same. If you or someone you love has been diagnosed with cancer after taking metformin or metformin ER, contact us today to find out if you are eligible for compensation through a metformin cancer lawsuit. NDMA is classified as a probable human carcinogen, meaning it could cause cancer in humans, and you could be at an increased risk for developing bladder cancer, stomach cancer, breast cancer, testicular cancer or another type of cancer if you took metformin to treat your diabetes.