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Five types of extended release metformin recalled over NDMA concerns

Metformin is an oral diabetes medication taken to control the blood sugar levels of the patient. ER Metformin stands for “extended release” metformin. Yesterday, the U.S. Food and Drug Administration announced that 5 companies have voluntarily recalled their ER Metformin over NDMA contamination concerns.


Recalled Companies/Products:

Apotex - all lots

Amneal - all lots

Marksans - branded as Time-Cap - one lot (XP9004)

Lupin - one lot (G901203)

Teva - branded as Actavis - 14 lots


As of the time of writing, in spite of there being other companies that produce ER Metformin, these are the only products being recalled. It’s also worth noting that “immediate release” metformin products have not been found to contain toxic levels of metformin. The FDA is asking that all companies producing ER Metformin “evaluate the risk that it contains BDMA at elevated levels.” Any batches/lots found to contain elevated levels should not be released to the public.

To read the full post on the voluntary recall, click here: