The FDA has ordered a recall of specific batches of generic metformin from three manufacturers after testing revealed NDMA levels exceeding acceptable daily intake limits by up to 10 times.
Affected Batches
The recall covers metformin hydrochloride extended-release tablets from Amneal, Apotex, and Lupin Pharmaceuticals. The contamination was discovered during routine FDA testing of generic drug quality.
Patient Guidance
Patients should not stop taking metformin without consulting their doctor, as the risk of uncontrolled diabetes outweighs the cancer risk from short-term exposure. Alternative batches are available.
- 3 manufacturers affected: Amneal, Apotex, Lupin
- NDMA levels 10x above safe limit
- Extended-release tablets only
- Do not stop medication without doctor consultation