Recall of diabetes medication over cancer-causing contaminant expanded

Recalls And Warnings

Courtesy FDA

(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.

S.No.Product NameNDC No.Pack SizeLot #Expiry Date
1.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500E037FOct-20
2.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990E072FOct-20
3.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990E074FOct-20
4.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000D086FOct-20
5.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500G011FOct-20
6.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990E076FOct-20
7.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP8260Oct-20
8.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000G012FNov-20
9.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990D096FNov-20
10.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990XP8276Nov-20
11.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500F001FNov-20
12.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990H029FNov-20
13.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990H031FNov-20
S.No.Product NameNDC No.Pack SizeLot #Expiry Date
14.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990XP8289Nov-20
15.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500H041FDec-20
16Metformin HCL ER Tablets
USP 500 mg
49483-623-0990L007FDec-20
17.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000L008FDec-20
18.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500L009FDec-20
19.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990J022FDec-20
20.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990H039FDec-20
21.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990J092FJan-21
22.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000K042FFeb-21
23.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500K051FJun-21
24Metformin HCL ER Tablets
USP 500 mg
49483-623-0990L055FJun-21
25.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990K079FJul-21
26.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000M001FJul-21
27Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A002GAug-21
28.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A003GAug-21
S.No.Product NameNDC No.Pack SizeLot #Expiry Date
29.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A007GAug-21
30.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A115GSep-21
31.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A010GSep-21
32.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A009GSep-21
33.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A49001Nov-21
34.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40001Dec-21
35.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40002Dec-21
36.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP0010Dec-21
37.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40003Dec-21
38.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40004Dec-21
39.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP0016Dec-21
40.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40005Dec-21
41.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40006Jan-22
42.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40007Jan-22
43.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40008Jan-22
S.No.Product NameNDC No.Pack SizeLot #Expiry Date
44.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40009Feb-22
45.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40010Mar-22
46.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990XP0036Mar-22
47.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40011Mar-22
48.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40012Mar-22
49.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP0046Apr-22
50.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40013Mar-22
51.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40014Apr-22
52.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40015Apr-22
53.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40016Apr-22
54.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40017Apr-22
55.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40018Apr-22
56.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100M125EOct-20
57.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100D001FNov-20
58.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100C084FNov-20
S.No.Product NameNDC No.Pack SizeLot #Expiry Date
59.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100F073FJan-21
60.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100E063FJan-21
61.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100F072FMar-21
62.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100J002FApr-21
63.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100J087FApr-21
64.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100K080FJun-21
65.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100L056FJun-21
66.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100M046FJul-21
67.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R9001Oct-21
68.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R9002Nov-21
69.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0001Dec-21
70.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0002Dec-21
71.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0003Mar-22
72.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100XR0016Mar-22
73.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0004Mar-22
S.No.Product NameNDC No.Pack SizeLot #Expiry Date
74.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0005Mar-22
75.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0006Apr-22
76.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0007Apr-22

Read more from the FDA on the recall.

Copyright 2020 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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