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Amneal Pharmaceuticals recalls Metformin Hydrochloride Extended Release Tablets

The medication may be contaminated with a probable cancer-causer

Photo source: FDA
Amneal Pharmaceuticals of Bridgewater, N.J., is recalling all lots of Metformin Hydrochloride Extended Release Tablets.

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

53746-178-01100 count bottles
53746-178-05500 count bottles
53746-178-101000 count bottles
53746-178-9090 count bottles
53746-178-BulkBulk Box
65162-178-0990 count bottles
65162-178-10100 count bottles
65162-178-111000 count bottles
65162-178-50500 count bottles

Metformin HCl Extended Release Tablets, USP, 750 mg

53746-179-011000 count bottles
53746-179-BulkBulk Box
65162-179-10100 count bottles

What to do

Consumers with questions may contact Amneal at (833) 582-0812 or by email at

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