RECALL INFORMATION: Metformin Hydrochloride Extended-Release Tablets

Date: 09/04/20

The U.S. Food and Drug Administration (FDA) recently announced a voluntary recall for Metformin Hydrochloride Extended-Release (ER) 500mg tablets and 750mg tablets due to N-Nitrosodimethylamine (NDMA) levels found in excess of Acceptable Daily Intake Limits (ADI). NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and foods.

At this time, recalls have affected only a limited number of manufacturers and lot numbers. Members affected by the recall may be switched to the several Metformin ER manufacturers whose products have not been recalled at this time. Additionally, switching to Metformin immediate-release formulation is also an option, as there have been no recalls associated with that formulation. For more information, please review the following article from the FDA: Recalls, Market Withdrawals, & Safety Alerts.

Metformin is used to control blood sugar levels in type 2 diabetes patients. Failure to take this medication regularly may cause a decline in health, including increased blood glucose/sugar. Over time, increased blood glucose/sugar can cause serious problems such as damage to the eyes, kidneys, nerves, heart and blood vessels.

Allwell from Superior HealthPlan, Ambetter from Superior HealthPlan and Superior HealthPlan Medicare-Medicaid Plan (MMP) are committed to the safety, health and well-being of members. Superior is working proactively to ensure members have the most appropriate and cost effective medications they need to maintain their health. Please take a few moments to review the Allwell, Ambetter and MMP formularies, located on Superior’s Pharmacy webpage, for available alternatives that may be suitable for your patient.

Please note: MMP has copay waived.

It is recommended to consider low-cost alternatives when appropriate, such as:

• Metformin (regular release) - Allwell, Ambetter, MMP
• Glipizide - Allwell, Ambetter, MMP
• Pioglitazone (caution in patients with cardiac disease) - Allwell, Ambetter, MMP

Other available alternatives that may be a higher cost include:

• Januvia - Allwell, Ambetter, MMP
• Tradjenta - Allwell, Ambetter, MMP
• Steglatro - Ambetter
• Invokana - Allwell, MMP
• Jardiance – Allwell, MMP

For questions or concerns, please reach out to Superior’s Pharmacy department by calling 1-800-218-7453, ext. 54019.