Granules Issues Recall of Metformin Hydrochloride Extended-Release Tablets

Granules Pharmaceuticals is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.

Granules’ test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batches distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market.

Granules Pharmaceuticals has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.

Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are not affected by this recall.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets USP, 750 mg lots subject to the recall is identified in the table below.

The complete list of recalled lots is available on the FDA website.

The affected Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, lots were distributed nationwide in the USA directly to Distributors, and Retailers. Granules Pharmaceuticals, Inc. is in the process of notifying its distributers and customers affected by this recall via mail (FedEx standard overnight) by mailing a recall notification letter and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.