FDA Citizen Petition #3: NDMA Carcinogen in Metformin
Valisure’s batch-level analysis of metformin, one of the most commonly prescribed medications for type 2 diabetes, uncovered elevated levels of NDMA, a probable human carcinogen. Testing across 38 batches from 22 different companies revealed that 16 batches from 11 manufacturers contained NDMA levels exceeding the FDA’s acceptable daily intake limit of 96 nanograms—with some batches surpassing that threshold by more than tenfold.
Valisure’s findings revealed significant inconsistencies in drug quality, even within the same manufacturer’s product lines, and underscored the critical need for chemical batch-level testing to detect harmful impurities that standard inspections might miss.
Following Valisure’s Citizen Petition, the FDA initiated product recalls from several major manufacturers, including Amneal, Apotex, Lupin, Marksans (Time-Cap), Teva (Actavis), and Granules.
Full Petition: Read the complete Citizen Petition →
Media Coverage Highlights:
- Bloomberg: Carcinogen Found by Pharmacy in Popular U.S. Diabetes Drug
- Business Insider: Online pharmacy Valisure says tests show carcinogen in diabetes drug metformin
- FDA News: Online Pharmacy Urges FDA to Pull Metformin Products With High NDMA Levels
- The People’s Pharmacy: Several Metformin Diabetes Drugs Contaminated with Nitrosamine
- The New York Times: Online Pharmacy Valisure Says Tests Show Carcinogen in Diabetes Drug Metformin
- MedPage Today: More Carcinogen-Tainted Drugs
- NASDAQ: Valisure Challenges FDA’s Claims on Metformin’s Safety
- Pharmacist.com: Carcinogen found by pharmacy in popular U.S. diabetes drug
- Pharmacy Times: High Levels of Carcinogen NDMA Found in Common Diabetes Medication
- Reuters: Online pharmacy Valisure says tests show carcinogen in diabetes drug metformin
