Highest risk U.S. Food and Drug Administration

Fouzee SugarLin Herbal Formula Herbal Dietary Supplement recall: Product contains undeclared Metformin and Glyburide

Recall published 1+ years ago

Product contains undeclared Metformin and Glyburide

Fouzee Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Metformin may pose a serious risk to consumers because this ingredient can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
December 16, 2024
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Fouzee
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

SugarLin Herbal Formula Herbal Dietary Supplement

What the company announced

FOR IMMEDIATE RELEASE – December 16, 2024 – Los Angeles, California - Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level . See Attachment 1 for photo of product labeling. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Metformin is the active ingredient in several FDA-approved prescription drugs used to treat type 2 diabetes and is only available with a prescription. Metformin may pose a serious risk to consumers because this ingredient can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated. Symptoms of lactic acidosis include nausea, vomiting, fatigue, body aches, respiratory distress, abdominal pain and fast, deep breathing. Metformin may also cause hypoglycemia when taken together with other medications to lower blood sugar.

Glyburide is the active ingredient in some FDA-approved prescription drugs used to treat type 2 diabetes and is only available with a prescription. Glyburide may pose serious and potentially life-threatening risks to consumers because this ingredient may result in unsafe drops in blood sugar levels (hypoglycemia). Common symptoms of hypoglycemia include fast heartbeat, shaking, sweating, nervousness or anxiety, irritability or confusion, dizziness, drowsiness, headache and hunger. Hypoglycemia may quickly become severe, resulting in seizures, coma or death.

This product was promoted and sold nationwide as a glucose or blood sugar support supplement on various websites including, www.shoppers-plaza.com and possibly in some retail stores.

The recalled Fouzee SugarLin Herbal Formula is packaged in a white bottle containing 180 veg capsules, with UPC 26656690477. See Attachment 1 for photo of product labeling,

Shoppers-Plaza is notifying its distributors and customers by email, its website ( https://shoppers-plaza.com/pages/recall-fouzee-sugarlin-notice ), and social media and is arranging for return of all recalled products.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers, distributors, and retailers that have FOUZEE SUGARLIN HERBAL FORMULA must immediately stop using the product and return all units of the product in their possession to the place of purchase. A full refund will be provided on the same platform from which the product was purchased.

Consumers with questions regarding this recall can contact BICO Legal and Compliance Consulting, LLC at:

Attention: Anthony Robinson, Esq.

Tel: 786/796-6708

Email: [email protected]

Hours: Monday to Friday 9am – 5pm Est.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Allergen

Fouzee — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Report any reaction to the FDA so it is recorded against this recall.
  3. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  4. If someone does avoid it, stop serving it and check anything already cooked with it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: A full refund will be provided on the same platform from which the product was purchased.

Company contact: Shoppers-Plaza — Consumers: BICO Legal and Compliance Consulting, LLC, Anthony Robinson, Esq., 786/796-6708, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fouzee prescription & otc drugs recalled?

Product contains undeclared Metformin and Glyburide Metformin may pose a serious risk to consumers because this ingredient can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: A full refund will be provided on the same platform from which the product was purchased.

Where was the recalled product sold?

It was distributed nationwide.

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