FDA Recall D-0138-2024

SUGARMDS LLC · Maryland Heights, MO

Class I — life-threatening Ongoing 918 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: LOT# 22165-003, EXP 09/30/2024

Quantity: 32,117

Reason for recall

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

Recall record

Recall number: D-0138-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: U.S. Nationwide and online websites.
Recall initiated: 2023-11-08
Classified by FDA Center: 2023-12-02
FDA published: 2023-12-13
Recalling firm: SUGARMDS LLC
Firm location: Maryland Heights, MO

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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