Elevated risk U.S. Food and Drug Administration

Supercore Products Group Dietary Supplements for Male Sexual Enhancement recall: Tainted with Sildenafil and Acetaminophen

Recall published 2+ years ago

Tainted with Sildenafil and Acetaminophen.

The hazard: Undeclared allergen or ingredient

This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

What the notice says: Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

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
July 10, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Supercore Products Group
Product type
Dietary supplements

Products covered by this recall

Dietary Supplements for Male Sexual Enhancement.

What the company announced

FOR IMMEDIATE RELEASE – 7/10/2024 – Atlanta, GA, Supercore Products Group is voluntarily recalling of Hard Steel Capsules & Gold Hard Steel Plus Liquid to the consumer level. FDA analysis has found these products to be tainted with Sildenafil and acetaminophen. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil in these products renders them an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.

Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, those who use nitrates for cardiac conditions are most at risk.

Acetaminophen is a medicine used to reduced pain and fever that is found in many prescriptions, and over-the-counter (OTC) drug products. Use of the products poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. Victims of unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.

As of to date, Supercore Products Group has not received any reports of adverse events related to this recall.

The recalled products are used as a male enhancement sold at https://hardsteelusa.com and are sold in single, 10ct, 20ct and 30ct packages. The affected Hard Steel Capsules include the following purchase period: January 5th, 2024 through July 5th, 2024. The product can be identified by its original packaging and black/white capsule or black/gold capsule. Gold Hard Steel Plus Liquids are sold in 2oz bottles. This product is sometime described as Hard Steel Gold 2oz Liquid Shots, packaged in black and gold bottles. Hard Steel is sold worldwide via Hardsteelusa.com .

Supercore Products Group is notifying its distributors and customers by email and is arranging for a return of all recalled products. Consumers, distributors, and retailers that have recalled Hard Steel Capsules, and/or Gold Hard Steel Plus Liquid should immediately stop use of the products and return it to place of purchase or discard.

Consumers with questions regarding this recall can contact Supercore Products Group at 800-573-5933 or e-mail: [email protected] Monday - Friday from 9:00am – 5:00pm EST. 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.

As Supercore Products Group take corrective action, the Company pledges to work vigorously to implement strategic measure to ensure the quality, safety, and protection of its brand.

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.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 ct
  • 20 ct
  • 30 ct
  • 2 oz

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Supercore Products Group — This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Consumers, distributors, and retailers that have recalled Hard Steel Capsules, and/or Gold Hard Steel Plus Liquid should immediately stop use of the products and return it to place of purchase or discard.

Company contact: Supercore Products Group — Consumers: Supercore Products Group, 800-573-5933, [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 Supercore Products Group dietary supplements recalled?

Tainted with Sildenafil and Acetaminophen. Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

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: Consumers, distributors, and retailers that have recalled Hard Steel Capsules, and/or Gold Hard Steel Plus Liquid should immediately stop use of the products and return it to place of purchase or discard.

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