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Apotex recalls Metformin Hydrochloride Extended-Release Tablets

The medication may be contaminated with a probable cancer-causer

Photo source: FDA
Apotex Corp. is recalling all lots of Metformin Hydrochloride Extended-Release Tablets.

One lot of the product, used as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients, was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer).

There are no reports of adverse events.

The following product, sold by prescription nationwide, is being recalled:

ProductStrengthPack SizeNDC Number
Metformin Hydrochloride Extended-Release Tablets, USP500mg100's Bottle60505-0260-1

What to do

Patients who have experienced any problems that may be related to taking or using the recalled product should contact their physician or healthcare provider.

Consumers with questions may contact Apotex at (800) 706-5575 from 8:30am – 5:00pm (EST) Monday thru Friday, or by email at

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