FDA testing of seven lots of the medication, used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer).
There are no reports of adverse events.
Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.
The following product, sold by prescription nationwide, is being recalled:
Metformin HCl Extended Release Tablets, USP, 500 mg
| 53746-178-01 | 100 count bottles |
| 53746-178-05 | 500 count bottles |
| 53746-178-10 | 1000 count bottles |
| 53746-178-90 | 90 count bottles |
| 53746-178-Bulk | Bulk Box |
| 65162-178-09 | 90 count bottles |
| 65162-178-10 | 100 count bottles |
| 65162-178-11 | 1000 count bottles |
| 65162-178-50 | 500 count bottles |
Metformin HCl Extended Release Tablets, USP, 750 mg
| 53746-179-01 | 1000 count bottles |
| 53746-179-Bulk | Bulk Box |
| 65162-179-10 | 100 count bottles |
What to do
Consumers with questions may contact Amneal at (833) 582-0812 or by email at AmnealproductrecallDS@amneal.com.