Class I Recall for Supplement Containing Undeclared Drugs

A Class I recall has been issued for 32,117 bottles of the dietary supplement Dr. Ergin’s SugarMD Advance Glucose Support after an analysis by the US Food and Drug Administration (FDA) identified undeclared metformin and glyburide in the capsules, according to the December 13, 2023, FDA Enforcement Report.

Metformin and glyburide are active ingredients found in several FDA-approved prescription drugs used to manage type 2 diabetes. Glyburide and metformin are only available with a prescription.

The recall affects Dr. Ergin’s SugarMD Advanced Glucose Support in 60-capsule bottles (UPC 00195893927678), 120-capsule bottles (UPC 00195893546978), and 180-capsule bottles (UPC 00195893999576) from lot 22165-003 (Exp. 9/30/24). The product was distributed throughout the United States through Amazon and sugarmds.com.

The firm SugarMDs voluntarily initiated the recall on November 8, 2023. On December 2, 2023, the FDA issued its Class I designation. The classification is the FDA’s strongest and warns use of the affected product could cause serious adverse health consequences or death.

Glyburide may cause unsafe drops in blood sugar levels, or hypoglycemia, which can cause seizures, coma, or death, according to the FDA. Metformin can cause a rare but serious side effect called lactic acidosis that, if untreated, can cause death. When taken with other medications to lower blood sugar, metformin may also cause hypoglycemia.

In a November 8, 2023, company announcement, SugarMDs said it had not received any reports of adverse events related to the recalled product.

Dr. Ergin’s SugarMD Advanced Glucose Support is a dietary supplement promoted and sold for blood glucose management.