7/12/24 Hard Steel Capsules & Gold Hard Steel Plus Liquid Dietary Supplements for Male Sexual Enhancement tainted with Sildenafil and acetaminophen are being recalled by Supercore Products Group.
The FDA analysis has found these products to be tainted w. Sildenafil which 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.comExternal Link Disclaimer.
ACTION
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.
CONTACT
Consumers with questions regarding this recall can contact Supercore Products Group at 800-573-5933 or e-mail: customersupport@hardsteelusa.com 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.