- Company announcement date: December 16, 2024
- FDA announcement date: December 18, 2024
- Company: Shoppers-Plaza
- Product: Fouzee SugarLin Herbal Formula
- Issue: Presence of undeclared Metformin and Glyburide
- Details: Packaged in white bottles containing 180 veg capsules (UPC 26656690477)
- Action: Stop using and return the product for a full refund
Stick around to learn more about what happened, why it matters, and how it impacts the industry.
What happened?
Shoppers-Plaza, based in Los Angeles, California, issued a voluntary nationwide recall for its Fouzee SugarLin Herbal Formula capsules on December 16, 2024. The recall was prompted by the discovery of undeclared active pharmaceutical ingredients, Metformin and Glyburide, both commonly prescribed for managing type 2 diabetes. The undeclared ingredients were identified during routine testing. These substances are FDA-approved for diabetes treatment but pose significant health risks when taken without medical supervision.
Product Details
Brand | Product | Size | UPC | Issue |
Fouze | SugarLin Herbal Formula | 180 capsules | 26656690477 | Undeclared Metmorfin& Glyburide |
What caused the issue?
The recall stems from the presence of undeclared Metformin and Glyburide:
- Metformin: Can lead to a rare but life-threatening condition known as lactic acidosis, characterized by nausea, vomiting, fatigue, abdominal pain, and rapid breathing. Metformin is a prescription medication commonly used to control blood sugar levels in people with type 2 diabetes. It works by reducing glucose production in the liver and improving the body’s sensitivity to insulin.
- Glyburide: May cause severe hypoglycemia (low blood sugar), with symptoms like sweating, dizziness, and confusion. In extreme cases, it could result in seizures or coma. Glyburide is also a prescription drug for type 2 diabetes that stimulates the pancreas to release insulin.
While no adverse events have been reported so far, the potential health risks are severe, particularly for individuals with existing medical conditions.
At-risk groups
- People without diabetes who consume the product unknowingly.
- Diabetics who are already on prescribed medications for glucose control.
- Vulnerable groups such as the elderly, pregnant individuals, or those with kidney impairments.
- What is Metformin? Metformin is a prescription medication used to manage type 2 diabetes. It lowers blood sugar levels by decreasing glucose production in the liver and increasing the body’s sensitivity to insulin.
- What is Glyburide? Glyburide is another prescription medication for type 2 diabetes. It works by stimulating the pancreas to produce more insulin, helping lower blood sugar levels.
- Why are these ingredients dangerous in supplements? Metformin and Glyburide can cause severe side effects if taken without medical supervision, including lactic acidosis and hypoglycemia, both of which can be life-threatening.
- What is lactic acidosis? Lactic acidosis is a rare but serious condition caused by lactic acid build-up in the blood. Symptoms include nausea, vomiting, fatigue, abdominal pain, and rapid breathing.
- What are the symptoms of hypoglycemia? Symptoms include sweating, dizziness, confusion, shaking, a fast heartbeat, and hunger. Severe cases can lead to seizures, coma, or death.
- Who is most at risk from these ingredients? People without diabetes, those already taking diabetes medications, and vulnerable groups like the elderly, pregnant individuals, or those with kidney issues are at higher risk.
- How did these ingredients end up in the product? The exact cause hasn’t been disclosed, but it could involve cross-contamination or deliberate addition without proper disclosure.
- What should I do if I have this product? Stop using the product immediately and return it to the place of purchase for a full refund.
- Have there been any reports of adverse effects? No adverse effects have been reported yet, but consumers should consult a healthcare provider if they experience any symptoms.
- How can I avoid similar risks in the future? Purchase supplements from reputable brands with transparent labeling and certifications. Always consult a healthcare professional before using dietary supplements.
Here’s what you should do
If you have purchased this product, take the following steps:
- Stop Usage: Immediately discontinue use of the Fouzee SugarLin Herbal Formula.
- Check the Label: Look for the UPC 26656690477 on the bottle.
- Return the Product: Return it to the place of purchase for a full refund.
- Report adverse reactions to FDA Medwatch
- Contact for Assistance:
- Phone: 786/796-6708
- Email: [email protected]
- Hours: Monday to Friday, 9 a.m. – 5 p.m. EST
Behind the brand
Shoppers-Plaza is a Los Angeles-based company specializing in herbal supplements. While they have marketed Fouzee SugarLin as a natural glucose support formula, the undeclared pharmaceutical ingredients contradict their branding.
This isn’t the first recall involving undeclared ingredients in herbal products. Similar recalls occurred last week regarding VidaSlim and Buy-Herbal’s supplements containing undeclared components. Buy-Herbal recalled the presence of Chlorpheniramine, Dexamethasone and Furosemide in their capsules, while VidaSlim recalled the presence of Yellow Oreander contamination in their supplements.
“In times of recalls, transparency and accountability define a brand’s values. Turning challenges into opportunities for improvement ensures stronger consumer relationships.” Eran Mizrahi, Source86’ CEO.
Ensuring safe eats
This recall underscores the importance of transparency and rigorous testing in the supplement industry. Undeclared ingredients erode consumer trust and pose significant health risks, particularly to vulnerable populations.
- For consumers: Highlights the need to purchase supplements from reputable brands with transparent labeling.
- For manufacturers: Reinforces the importance of stringent quality control and sourcing practices.
- For the industry: Calls attention to regulatory oversight gaps in the supplement market.
For more insights and high-quality ingredients, feel free to reach out to the Source86’ team or explore our range of trusted, bulk ingredients!
