Safety Report: Hard Steel Capsules & Gold Hard Steel Plus Liquid recalled due to Sildenafil and Acetaminophen, USA

United States

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. Hard Steel is sold worldwide online via their website.

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.

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.

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.

The recalled products are used as a male enhancement 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.

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Supercore Products Group
Brand name: Supercore Products Group
Product recalled: Dietary Supplements for Male Sexual Enhancement.
Reason of the recall: Tainted with Sildenafil and Acetaminophen.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supercore-products-group-inc-issues-voluntary-worldwide-recall-hard-steel-capsules-gold-hard-steel