Over the past several months, a number of Metformin recalls have caused concern and near-panic in the healthcare community and among consumers. Various batches of Metformin have been recalled due to containing higher-than-acceptable levels of the carcinogen N-Nitrosodimethylamine (NDMA). Now, the already significant diabetes drug recall has expanded once again.
What began in March 2020 with the U.S. Food and Drug Administration (FDA) urging manufacturers to recall Metformin has now become a massive series of recalls of one of the most popular diabetes drugs in America. Estimates suggest that around 21 million people are prescribed Metformin each year.
Diabetes Drug Recall Expands
Months after the first diabetes drug recalls were issued, an increasing number of medications are being recalled for high levels of NDMA. The most recent recall comes from India-based Marksans Pharma Limited. Marksans is expanding their current Metformin recall to include an additional 76 lots of unexpired drugs. The recall includes 500 mg and 750 mg lots of Metformin Hydrochloride extended release tablets. According to the diabetes drug recall notice,
“[Marksans] performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.”
Marksans says that they are notifying distributors and customers via notification letters. They are also arranging for replacement or return of recalled products. The full list of affected products can be found on the FDA website.
The FDA urges consumers to continue taking their medication even if it is subject to this or another diabetes drug recall. Talk to your healthcare provider about a replacement or alternative treatment method.
Diabetes Drug Recall History
In March 2020, the FDA began warning consumers about the risks of NDMA exposure in batches of Metformin. Since then, several manufacturers have recalled their products, including:
- Apotex Corp.
- Amneal Pharmaceuticals LLC
- Bayshore Pharmaceuticals LLC
- Lupin Pharmaceuticals Inc.
- Teva Pharmaceuticals USA, Inc.
All of these manufacturers have found NDMA levels above the acceptable daily intake level. There are currently no reports of adverse events, but the FDA is warning consumers about the risks of NDMA exposure.
Risks of NDMA Exposure
NDMA is a probable human carcinogen, meaning it is a substance that can cause cancer. NDMA naturally occurs in the environment, including in some foods and water. In the natural environment, the levels of NDMA are very low and are not generally dangerous.
In higher concentrations, however, NDMA is potentially dangerous. Exposure to NDMA can cause the following side effects:
Tumors developing due to NMDA may become cancerous. The FDA also notes that continued exposure to NDMA increases the risk of cancer in patients taking contaminated medications.
Concerned about Contaminated Metformin?
If you take Metformin regularly to treat your diabetes, it is only natural that you have concerns about this diabetes drug recall. You rely on your medication to treat your diabetes and manage symptoms, not cause completely unrelated healthcare concerns.
If you have concerns about your Metformin, talk to your healthcare provider. Ask him or her about an alternative medication or treatment option. Never stop taking your Metformin without the guidance of a healthcare provider.
If you have concerns about diabetes drug recalls, visit the FDA’s Recall, Market Withdrawals & Safety Alerts page. Here, you can find information about specific recalls, as well as manufacturer information. You can contact a manufacturer directly to learn more about their recalled products.
If you have concerns about a diabetes drug recall and your legal rights, contact Drug and Device Watch. Our legal professionals can help you understand your rights as a consumer. If you have experienced serious side effects or complications while taking a recalled medication, we can also help you explore your options for possible financial recovery. To request a free case evaluation, call us at 1-888-458-6825.