Safety Report: Noah’s Wholesale, LLC Dietary Supplement - recalled due to undeclared Sildenafil, USA

United States

Noah’s Wholesale, LLC is voluntarily recalling one lot of rock# 03032021, exp:12/2027, 1200 mg/capsule, to the consumer level. FDA analysis has found the product to be tainted with Sildenafil. The product was distributed locally through convenience stores and some island jobbers (small wholesale distributors to retail). Noah’s Wholesale has not received any reports of adverse events related to this recall to date.

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 this product renders the rock an unapproved drug for which the safety and efficacy have 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, adult males who use nitrates for cardiac conditions are most at risk.

The Rock is marketed as a dietary supplement for male sexual enhancement and is packaged as a single pill in a blister pack. It is labeled as ORIGINAL THE ROCK, Male sexual performance, with the following UPC 6 61799 95052 7. Distributed by: Steele Products, Hallandale, FL. The Rock affected lot is lot#03032021, Exp:12/2027. The product can be identified by the red and black lettering on a white-flat small cardboard package with one red capsule seen through a clear blister window.

Noah’s Wholesale is notifying its distributors and customers by phone, emails, and through their sales representative and is arranging for a full refund/credit of all recalled products. Consumers who have the recalled product should stop using the product and return it to the place of purchase or discard the product immediately. Distributors and retailers should stop selling the product and contact Noah’s Wholesale LLC for a refund process.

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.

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: Noah’s Wholesale, LLC
Brand name: Noah’s Wholesale, LLC
Product recalled: Dietary Supplement with undeclared Sildenafil
Reason of the recall: Undeclared drug, Sildenafil
FDA Recall date: November 21, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/noahs-wholesale-llc-issues-voluntary-nationwide-recall-rock-due-presence-undeclared-sildenafil