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Add Bayshore Pharmaceuticals to the list of recalled diabetes drug companies due to NDMA

Bayshore Pharmaceuticals is the sixth metformin manufacturer to issue a recall due to a possible NDMA contamination. The recalled products were manufactured in Bangladesh in June of 2019, and distributed across the United States. If you've purchased any of the recalled medications, you should return them to your retailer or dispose of them immediately.


Recalled Products:

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg

NDC Number: 76385-128-10

Lot Number: 18641

Expiration: May 2021


Metformin Hydrochloride Extended-Release Tablets USP, 750 mg

NDC Number: 76385-129-01

Lot Number: 18657

Expiration: May 2021


The recall is the result of independent testing by the U.S. Food and Drug Administration and Bayshore. Initially, the FDA conducted their own tests. They reported their findings of increased NDMA levels to Bayshore, and then Bayshore conducted their own tests in house. The findings of these tests is what led to the recall of two varieties of their version of metformin. So far, Bayshore Pharmaceuticals isn’t aware of any illnesses related to their recalled medications.

In spite of the extensive list of recalled diabetes medications, the availability of metformin drugs shouldn’t be a concern. As the FDA explains, “there are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled." While other options remain for patients, let's hope we don't see anymore metformin recalls.

To read the full article from Fierce Pharma, click here: