The Recall Desk
SevereFDA (Drugs)·D-0138-2024·Announced 2023-12-13

Dietary supplement recalled for unapproved drug status and pharmaceutical contamination

Dr. Ergin's SugarMD glucose support capsules are recalled nationwide because they were marketed without FDA approval and are contaminated with the pharmaceutical ingredients metformin and glyburide. Approximately 32,117 units were distributed in the U.S.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This product is classified as FDA Class I, which establishes a minimum severity of 4. Although no illnesses or injuries have been reported, the product was marketed without FDA approval while containing pharmaceutical ingredients metformin and glyburide, creating a serious risk of adverse effects and drug interactions.

Plain-English summary

Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, marketed as a dietary supplement, is being recalled nationwide. The product is manufactured for SUGARMDS LLC and was distributed in 60, 120, and 180 count bottles.

The dietary supplement was marketed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product is contaminated with metformin and glyburide, which are prescription pharmaceutical ingredients used to treat diabetes. This poses a serious health risk because consumers purchasing this as a supplement may unknowingly consume prescription medications, potentially causing dangerous drug interactions with their other medications or adverse health effects.

The recalled product includes LOT# 22165-003 with expiration 09/30/2024. Approximately 32,117 units were distributed throughout the United States and online. Consumers who have purchased this product should discontinue use immediately and contact a healthcare provider, particularly if they are taking medications for diabetes or any other conditions.

The recalled product

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 34
Manufacturer
SUGARMDS LLC
Hazard
  • unapproved-drug
  • metformin
  • glyburide

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • LOT# 22165-003
  • EXP 09/30/2024

Distribution

Distributed nationwide across the United States.