Laboratory Tests | Metformin
Laboratory analysis of metformin products
FDA continues to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in metformin approved for sale in the U.S. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. FDA testing has found NDMA in certain lots of extended release (ER) metformin and is recommending companies recall lots with levels of NDMA above the acceptable intake limit of 96 nanograms per day.
FDA is posting its laboratory results in the table below showing NDMA amounts in metformin products it tested. FDA is also collaborating with international regulators to share testing results for metformin.
For reference, consuming up to the acceptable daily intake limit, 0.096 micrograms (96 nanograms), of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. NDMA may increase the risk of cancer if people are exposed to it above the acceptable level and over a long period of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.
| Company (from container label) | Product | Lots Tested | NDMA level (micrograms-mcg/tablet) |
|---|---|---|---|
| Heritage | Rx Metformin 1000mg IR* | 4521603A, 4521611A, 4521630A | not detected |
| Heritage | Rx Metformin 850mg IR | 4510157A | not detected |
| Heritage | Rx Metformin 500mg IR | 4500753A | not detected |
| Ingenus Pharmaceuticals | Rx Metformin 1000mg ER** | 19088003 | not detected |
| Ingenus Pharmaceuticals | Rx Metformin 500mg ER | 19388005 | 0.01 |
| Actavis | Rx Metformin 1000mg ER | 1358454A, 1358453A, 1358452A | 0.01-0.02 |
| Actavis | Rx Metformin 500mg ER | 1358450A, 1358451A, 1358449A, 1376339M | 0.01-0.02 |
| Actavis | Rx Metformin 750mg ER | 1354471A | 0.04 |
| Sun Pharma | Rx Metformin 1000mg ER | GKU0762, GKU0763, GKU0764 | not detected |
| Sun Pharma | Rx Metformin 750mg ER | JKU0880A | not detected |
| Sun Pharma | Rx Metformin 500mg ER | GKU06060, JKU2539A | not detected |
| Westminster Pharmaceuticals | Rx Metformin 1000mg IR | D107031, B107261B | not detected |
| Westminster Pharmaceuticals | Rx Metformin 500mg IR | B105067B | not detected |
| Aurobindo | Rx Metformin 1000mg IR | MTSC19039-A | not detected |
| Aurobindo | Rx Metformin 500mg IR | MTSC19016-B, MTSA19070-C | not detected |
| Major Pharmaceuticals | Rx Metformin 1000mg IR | M02599D | not detected |
| Epic Pharma LLC | Rx Metformin 1000mg ER | 191000111, 191000411, 191000211, 191001011, 191001311 | not detected |
| Epic Pharma LLC | Rx Metformin 500mg ER | 190101111 | 0.005 |
| Ascend | Rx Metformin 1000mg IR | 4200056A, 4200064A, 4200077A, 4200038A, 4200061B, 4200024C | not detected |
| Ascend | Rx Metformin 500mg IR | 4980028B | not detected |
| Amneal | Rx Metformin 500mg ER | AM191247A, AM190755A, AM190934A, AM190107AA, HD03319A, HM02918A | 0.06-0.19 |
| Amneal | Rx Metformin 750mg ER | AM180770A | 0.08 |
| Amneal | Rx Metformin 850mg IR | AM180405A | 0.01 |
| ACI Healthcare USA, Inc | Rx Metformin 500mg IR | D105061, C105019A, D105019 | not detected |
| Aiping Pharmaceutical, Inc | Rx Metformin 500mg ER | 190300211 | not detected |
| Aiping Pharmaceutical, Inc | Rx Metformin 1000mg ER | 190200411 | not detected |
| Zydus | Rx Metformin 1000mg ER | 184759 | not detected |
| Apotex Corp | Rx Metformin 500mg ER | NE5801 | 0.06 |
| Apotex Corp | Rx Metformin 750mg ER | NG2595 | not detected |
| Granules Pharma Inc | Rx Metformin 500mg ER | 4910134A | not detected |
| Lupin Pharma | Rx Metformin 500mg ER | G901203 | 0.09 |
| Megalith Pharmaceuticals | Rx Metformin 1000mg IR | 442180318 | not detected |
| Mylan Pharmaceuticals | Rx Metformin 1000mg ER | 3090719 | 0.01 |
| Nostrum Labs Inc | Rx Metformin 1000mg ER | MEF290206 | not detected |
| Oceanside | Rx Metformin 500mg ER | 19D125P | not detected |
| Tagi Pharma | Rx Metformin 500mg ER | 5841910035, 5841905129 | not detected-0.01 |
| Time Cap Lab | Rx Metformin 500mg ER | XP9004 | 0.04 |
*Immediate release
** Extended release