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Lupin Pharmaceuticals recalls Metformin Hydrochloride Extended-Release Tablets

The medication may be contaminated with a probable cancer-causer

Photo source: FDA
Lupin Pharmaceuticals is recalling one lot of Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet).

Analysis shows the prescription oral medication, used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus, exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA).

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

The firm has not received any reports of adverse events to date.

The following product, packaged in a bottle containing 60 tablets, is being recalled:

Product Name


Lot Number

Expiration Date

Metformin Hydrochloride Extended-Release Tablets USP, 500mg68180-336-07G90120312/2020

It was shipped nationwide to wholesalers, distributors, and mail order pharmacies.

What to do

Patients taking the recalled medication should continue to do so and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Consumers with questions may contact Inmar Rx Solutions at (855) 532-1856 Monday – Friday, 9:00 am to 5:00 pm (EST).

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