FDA recall D-0138-2024

Product

Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.

Reason for recall

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

Distribution

U.S. Nationwide and online websites.

Key facts

Status

Ongoing

Initiation date

2023-11-08

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maryland Heights, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0138-2024