A male doctor in a white coat, holding a prescription bottle,facing a patient.

Explaining Our Product Recall for Metformin

Summary

  • SugarMD initiated a voluntary nationwide recall of a specific lot of its Advanced Glucose Support supplement after the FDA found undeclared prescription drugs, glyburide and metformin, in the product.
  • The recall was voluntary, initiated by SugarMDs on November 8, 2023, and not mandated by the FDA. No adverse events were reported.
  • These hidden ingredients can cause serious health risks, including dangerously low blood sugar (hypoglycemia) and a life-threatening condition called lactic acidosis, especially for people already on other medications or with existing health issues.
  • Customers who purchased the product are instructed to immediately stop using it, check their bottle for the lot number (LOT #22165-003), and safely dispose of it in accordance with FDA guidelines.
  • All units from this lot are no longer in circulation.
  • To prevent future issues, SugarMD has terminated its relationship with the manufacturer, implemented triple-phase quality screening, and expanded third-party testing across all products.
  • The company is offering a 48-hour refund turnaround for affected customers and providing free consultations with health advisors to address any concerns.
  • For Dr. Ergin's personal statement on this recall, please read A Message from Dr. Ahmet Ergin on the FDA Recall of Advanced Glucose Support.

When you buy a health supplement, you're placing your trust in the brand. You trust that what's on the label is what's inside the bottle. In 2023, we learned that a former manufacturer we worked with didn't meet our standards, which resulted in a breach of that trust. We are writing this blog post with full transparency to explain the voluntary recall of a specific lot of our SugarMD Advanced Glucose Support product.

We want to make sure you have all the information you need about what happened, why it matters for your health, and the steps we have taken to prevent this from ever happening again.

Why We Initiated This Voluntary Recall

Our mission at SugarMD has always been to provide our customers with science-backed, high-quality products. We take this responsibility very seriously. That is why, as soon as we were notified of the U.S. Food & Drug Administration's (FDA) findings, we acted immediately, without waiting to be asked.

The FDA conducted lab tests on a specific lot of our Advanced Glucose Support and found that it contained undeclared prescription ingredients. These ingredients were glyburide and metformin, both of which are active ingredients in FDA-approved prescription drugs used to treat Type 2 diabetes. Because these ingredients were not listed on the product label, we initiated a voluntary nationwide recall of the affected product on November 8, 2023. This decision was ours; it was not mandated by the FDA. No adverse events were reported in connection with this lot.

We cooperated fully with the FDA, reviewed every aspect of our sourcing and manufacturing, and took complete accountability for what happened.

What Caused the Contamination

The affected lot was manufactured in a facility that also produced prescription metformin products. Cross-contamination between products is a documented risk in shared manufacturing environments, even under controlled conditions. Once we understood the root cause, we immediately addressed it by terminating that manufacturing relationship and moving to facilities with stricter product-separation standards. All recalled units from LOT #22165-003 have been fully accounted for and are no longer in circulation.

Health Risks & Safety Information

It is extremely important for you to understand why these undeclared ingredients pose a health risk, especially if you have an underlying health condition.

Potential Dangers of Undeclared Ingredients

  • Glyburide Risks: This is a powerful diabetes medication that works by stimulating the pancreas to produce more insulin. If you are taking this without a doctor's supervision or if you are on other medications that lower blood sugar, it can lead to severe hypoglycemia, a condition where your blood sugar drops to dangerously low levels.
    • Symptoms can include dizziness, sweating, shaking, and, in severe cases, seizures, coma, or even death. Glyburide can also interact with other medications, particularly blood thinners, which can increase your risk of bleeding.
  • Metformin Risks: Metformin is another effective diabetes drug. However, in vulnerable individuals, it can cause a rare but serious side effect called lactic acidosis, which is a life-threatening buildup of lactic acid in the blood.
    • Symptoms can include unusual muscle pain, fatigue, nausea, and difficulty breathing. Metformin can also put extra stress on the kidneys.

Who Is Most Vulnerable?

The risks associated with these ingredients are especially high for certain individuals, including:

  • Patients who are already taking other diabetes medications.
  • People on blood thinners, such as warfarin, or certain blood pressure drugs.
  • Anyone with existing kidney disease, liver issues, or who is pregnant.

If you fall into any of these categories and have taken this product, we urge you to contact your doctor immediately.

Step-by-Step: What Customers Must Do

  • Check Your Bottle: Check the label of your SugarMD Advanced Glucose Support bottle for the lot number. The affected product is LOT #22165-003. This lot was distributed in 60-count (UPC: 00195893927678), 120-count, and 180-count bottles.
  • Discontinue Use Immediately: If you have a bottle from the affected lot, do not take another dose.
  • Safe Disposal: Please do not simply throw the product in the trash, as it contains pharmaceutical ingredients. We ask that you return the product to its place of purchase. Alternatively, you can follow the FDA's guidelines for drug take-back programs or consult with your local pharmacy for safe disposal options.
  • Request Refund/Support: We are committed to making this right. For a full refund or to ask any questions, please email us at feedback@sugarmds.com or call us at +1 888 374 3710. We are ready to help you.

How SugarMD Is Preventing Future Issues

We understand that a voluntary recall like this can shake your confidence. We are working to not only fix this immediate issue but to rebuild and strengthen the trust you place in us.

Immediate Corrective Actions

  • Supply Chain Overhaul: We have immediately and permanently terminated our relationship with the manufacturer that supplied this product and moved production to facilities with stricter product-separation standards.
  • Enhanced Testing Protocol: We have implemented a new triple-phase quality screening process covering raw materials, the production process, and final batch release. We have also expanded third-party testing across all products.

Long-Term Safety Upgrades

  • Transparency Pledge: Every current SugarMD product is third-party tested and GMP certified, held to a higher standard than what existed before 2023. We are committed to making batch-specific lab reports publicly available so you can verify the safety and quality of every product you purchase.
  • Third-Party Audits: We have engaged independent third-party auditors to conduct quarterly inspections of our manufacturing facilities, ensuring compliance with or exceeding FDA standards.

Your Questions Answered

1. Was this product sold in stores?

This product was sold primarily through our website, SugarMD.com. We notified all affected customers directly and offered full refunds to everyone involved.

2. Are other SugarMD products affected?

No. This recall is strictly limited to LOT #22165-003 of our Advanced Glucose Support product. No other SugarMD product, including Super Berberine, Neuropathy Support, or any other supplement in our current line, was part of this recall. All recalled units have been accounted for and are no longer in circulation.

3. What if I already took this product?

If you have taken the product and have any concerns, please contact your doctor or another healthcare professional immediately. You should also reach out if you experience any unusual symptoms, such as dizziness, sweating, muscle pain, or nausea. Please also consider reporting your experience via the FDA MedWatch program.

Our Commitment to You

There is no way to fully express our disappointment and frustration over this incident. We see this breach of trust as unacceptable and have pledged to do better. We are dedicating 100% of all revenue generated from the recalled product to independent diabetes research to support the community we have failed to serve on this occasion.

We are standing by a 48-hour refund turnaround for all affected customers. Our health advisors are also available for free consultations to answer any health-related questions you may have about this issue.

We are deeply sorry for any concern this has caused you and your loved ones. We hope that our full transparency and commitment to a higher standard of quality will begin to rebuild your trust in us.

Official Resources & Contacts