Recall of diabetes medication over cancer-causing contaminant expanded
Testing on staging11
(NewsNation Now) — A recall of the commonly prescribed diabetes drug Metformin has expanded over concerns of high levels of a cancer-causing contaminant, the FDA announced earlier this week.
Metformin is used to treat type 2 diabetes and helps to control high blood sugar.
An additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, and 750mg may contain levels of a cancer-causing contaminant higher than the acceptable daily intake limit.
Marksans Pharma Limited, India, voluntarily expanded the recall after it was initially issued back in June to include 76 unexpired lots of the medication. Marksans performed tests on the unexpired marked lots and observed levels of N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen or a substance that could cause cancer, in excess of the acceptable Daily Intake Limit (ADI) of 96ng/day.
According to the release from the FDA, “Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.”
The FDA says consumers taking the recalled medication should continue taking it until a doctor or pharmacist gives them a replacement or another treatment option, as it could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.
The FDA says the following are included in the expanded recall. The lot number can be found on the side panel of bottle labels as well as shipper/case labels.
Recall tables not showing in the app? Click here to view
| S.No. | Product Name | NDC No. | Pack Size | Lot # | Expiry Date |
|---|---|---|---|---|---|
| 1. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | E037F | Oct-20 |
| 2. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | E072F | Oct-20 |
| 3. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | E074F | Oct-20 |
| 4. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | D086F | Oct-20 |
| 5. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | G011F | Oct-20 |
| 6. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | E076F | Oct-20 |
| 7. | Metformin HCL ER Tablets USP 500 mg | 49483-623-01 | 100 | XP8260 | Oct-20 |
| 8. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | G012F | Nov-20 |
| 9. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | D096F | Nov-20 |
| 10. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | XP8276 | Nov-20 |
| 11. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | F001F | Nov-20 |
| 12. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | H029F | Nov-20 |
| 13. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | H031F | Nov-20 |
| S.No. | Product Name | NDC No. | Pack Size | Lot # | Expiry Date |
|---|---|---|---|---|---|
| 14. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | XP8289 | Nov-20 |
| 15. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | H041F | Dec-20 |
| 16 | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | L007F | Dec-20 |
| 17. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | L008F | Dec-20 |
| 18. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | L009F | Dec-20 |
| 19. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | J022F | Dec-20 |
| 20. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | H039F | Dec-20 |
| 21. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | J092F | Jan-21 |
| 22. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | K042F | Feb-21 |
| 23. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | K051F | Jun-21 |
| 24 | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | L055F | Jun-21 |
| 25. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | K079F | Jul-21 |
| 26. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | M001F | Jul-21 |
| 27 | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A002G | Aug-21 |
| 28. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A003G | Aug-21 |
| S.No. | Product Name | NDC No. | Pack Size | Lot # | Expiry Date |
|---|---|---|---|---|---|
| 29. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A007G | Aug-21 |
| 30. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A115G | Sep-21 |
| 31. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A010G | Sep-21 |
| 32. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | A009G | Sep-21 |
| 33. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A49001 | Nov-21 |
| 34. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40001 | Dec-21 |
| 35. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | A40002 | Dec-21 |
| 36. | Metformin HCL ER Tablets USP 500 mg | 49483-623-01 | 100 | XP0010 | Dec-21 |
| 37. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40003 | Dec-21 |
| 38. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | A40004 | Dec-21 |
| 39. | Metformin HCL ER Tablets USP 500 mg | 49483-623-01 | 100 | XP0016 | Dec-21 |
| 40. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40005 | Dec-21 |
| 41. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A40006 | Jan-22 |
| 42. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A40007 | Jan-22 |
| 43. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A40008 | Jan-22 |
| S.No. | Product Name | NDC No. | Pack Size | Lot # | Expiry Date |
|---|---|---|---|---|---|
| 44. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40009 | Feb-22 |
| 45. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40010 | Mar-22 |
| 46. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | XP0036 | Mar-22 |
| 47. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A40011 | Mar-22 |
| 48. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | A40012 | Mar-22 |
| 49. | Metformin HCL ER Tablets USP 500 mg | 49483-623-01 | 100 | XP0046 | Apr-22 |
| 50. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40013 | Mar-22 |
| 51. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | A40014 | Apr-22 |
| 52. | Metformin HCL ER Tablets USP 500 mg | 49483-623-09 | 90 | A40015 | Apr-22 |
| 53. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A40016 | Apr-22 |
| 54. | Metformin HCL ER Tablets USP 500 mg | 49483-623-10 | 1000 | A40017 | Apr-22 |
| 55. | Metformin HCL ER Tablets USP 500 mg | 49483-623-50 | 500 | A40018 | Apr-22 |
| 56. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | M125E | Oct-20 |
| 57. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | D001F | Nov-20 |
| 58. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | C084F | Nov-20 |
| S.No. | Product Name | NDC No. | Pack Size | Lot # | Expiry Date |
|---|---|---|---|---|---|
| 59. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | F073F | Jan-21 |
| 60. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | E063F | Jan-21 |
| 61. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | F072F | Mar-21 |
| 62. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | J002F | Apr-21 |
| 63. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | J087F | Apr-21 |
| 64. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | K080F | Jun-21 |
| 65. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | L056F | Jun-21 |
| 66. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | M046F | Jul-21 |
| 67. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R9001 | Oct-21 |
| 68. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R9002 | Nov-21 |
| 69. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0001 | Dec-21 |
| 70. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0002 | Dec-21 |
| 71. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0003 | Mar-22 |
| 72. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | XR0016 | Mar-22 |
| 73. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0004 | Mar-22 |
| S.No. | Product Name | NDC No. | Pack Size | Lot # | Expiry Date |
|---|---|---|---|---|---|
| 74. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0005 | Mar-22 |
| 75. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0006 | Apr-22 |
| 76. | Metformin HCL ER Tablets USP 750 mg | 49483-624-01 | 100 | 9R0007 | Apr-22 |
Read more from the FDA on the recall.