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.

• 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 specific lot number (LOT #22165-003), and safely dispose of it according to FDA guidelines.

• To prevent future issues, SugarMD has terminated its relationship with the manufacturer, implemented new, rigorous testing protocols, and is launching a public quality dashboard for full transparency.

• The company is offering a 48-hour refund turnaround for affected customers and providing free consultations with health advisors to address any concerns.

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. Recently, 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 took immediate action.

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.

We are fully cooperating with the FDA's investigation to understand how this happened and to ensure that all of the affected products are removed from the market. We deeply regret that this has caused concern and want to assure you that your health and safety are our top priority.

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

To ensure your safety, we have created a clear, step-by-step guide for what you need to do if you purchased this product.

1. Check Your Bottle: First, check the label of your SugarMD Advanced Glucose Support bottle. Look for the Lot number. The affected product is LOT #22165-003. This lot was distributed in 60, 120, and 180-count bottles.

2. Discontinue Use Immediately: If you have a bottle from the affected lot, do not take another dose.

3. 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.

4. Request Refund/Support: We are committed to making this right. For a full refund or to ask any questions, please email our support team at support@sugarmds.com or call us at [Insert SugarMD Support Number]. 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. We are taking the following immediate and long-term actions to ensure our products are of the highest quality.

Immediate Corrective Actions

• Supply Chain Overhaul: We have immediately and permanently terminated our relationship with the manufacturer who supplied this product. We are now onboarding a new manufacturer that is fully GMP-certified and meets a higher standard of excellence.

• Enhanced Testing Protocol: We are implementing a new triple-phase screening process to test every product batch for contaminants before and after production. Our goal is to make these batch-specific lab reports publicly available in the near future.

Long-Term Safety Upgrades

• Transparency Pledge: We are launching a real-time quality dashboard on our website in Q3 2024. This will allow you to see the safety and quality data for every batch of our products.

• Third-Party Audits: We are also bringing in independent third-party auditors to conduct quarterly inspections of our new manufacturing facilities, ensuring they align with or exceed FDA standards.

Your Questions Answered

We know you probably have more questions, so we want to address some of the most common ones directly.

• Q: Was this product sold in stores?

• This product was sold primarily through our website, SugarMD.com. We are in the process of notifying the limited number of retailers who may have carried it.

• Q: Are other SugarMD products affected?

• No. This recall is limited to a single lot of our Advanced Glucose Support product, LOT #22165-003. All other SugarMD products remain safe and are not part of this recall.

• Q: 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 like 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 also standing by a customer support promise to provide 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 new standard of quality will begin to rebuild your trust in us.

Official Resources & Contacts

For more information, please use these official resources:

• FDA Recall Notice: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-hidden-drug-ingredients-dr-ergins-sugarmd-advanced-glucose-support

• SugarMD Support Email: support@sugarmds.com 

• Medical Emergencies: Call 911 or visit your nearest Emergency Room.