Metformin ER Recall Information

FDA issues voluntary recall of some metformin products: What does this mean for me?

There was a story that broke earlier this winter that piqued some interest in the diabetes community about the FDA investigating metformin for possible recall, but the FDA did not deem it necessary then, but following private labs finding higher levels than the FDA’s testing the FDA has changed course.

On May 28^th the FDA recommended a recall of metformin ER products from 5 manufacturers (Apotex Corp, Actavis/Teva Pharmaceuticals, Amneal, and Time-Cap Labs Inc./Marksans Pharma limited, Sun Pharma’s Riomet Metformin oral suspension ) due to unacceptably high levels of a chemical called N-nitrosodimethylamine (NDMA).

NDMA is a chemical found naturally in food and water supplies that, in low levels, is not harmful. However, in high concentrations, NDMA may have carcinogenic properties and have been linked to organ damage.

It is also of interest to note that earlier this year we saw a widespread recall of over the counter Rantidine (Zantac) products due to the presence of the same NDAM impurity that was found to increase over the shelf-life of the medication and when medications were stored at higher temperatures.

There is no information, at this time, as to the impact of shelf-life or storage temperature on metformin products.

How do I know if my medication is recalled?

You can check the manufacturer of your medication, it is typically listed in fine print under the medication brand name with the prefix MFG or MFR.

On some bottles, it may be on the side panel of the medication listed with safety warnings, and storage information.

If your medication lists the impacted manufacturers:

• Apotex Corp
• Actavis/Teva Pharmaceuticals
• Amneal
• Time-Cap Labs Inc./Marksans Pharma limited
• Sun Pharma’s Riomet Metformin oral suspension 

Reach out to your pharmacy to request a new stock of medication. If you can not find this information you can reach out to your pharmacist who will have the manufacturer of your medication available.

There are many manufacturers of Metformin ER products that have been tested and cleared by the FDA.

What do I do if I have or have been taking medication in the recall?

Do not stop taking your medication. The immediate health risks of high blood sugars and diabetes complications are far greater than possible exposure to this chemical. Reach out to your pharmacy for replacement medication and to your prescriber if a new prescription is needed.

You can find the FDA recalls here to share with your prescriber or pharmacist.

What are my health risks from exposure?

Human study data is really lacking and animal study data on the impacts of NDMA are unclear. The World Health Organization has compiled data that shows high levels of exposure over time have been linked to a higher risk of developing some cancers. NDMA has also been linked to enlargement of the spleen, liver failure, hemorrhage, cirrhosis of the liver & jaundice. However, these have all been noted in high dose long term exposure of foodstuffs. Immunologic effects and reproductive effects have been seen at extremely high doses in lab animal studies only.

(https://www.who.int/ipcs/publications/cicad/en/cicad38.pdf)

We encourage our community to be vigilant and stay connected to reliable sources of information with regards to any medications or technologies used, and to maintain good communication with your pharmacy resources.