Safety Report: WEFUN Capsules - recalled due to Undeclared Sildenafil, USA

United States

Hua Da Trading Inc dba Wefun Inc. is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall. This product was distributed Nationwide in the USA via internet sales via amazon.com and eshoponlineusa.com. WEFUN Inc has not received any reports of adverse events related to this 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 tainted WEFUN Capsules is marketed as a dietary supplement and is packaged in a blue cardboard box (10 capsules). The affected WEFUN Capsule lot includes the following #18520168 and 09/30/2026.

Hua Da Trading Inc dba Wefun Inc is notifying its distributors and customers by email and is arranging for return of all recalled WEFUN capsules. Consumers/distributors/retailers that have WEFUN capsules which is being recalled should stop using and return 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: Hua Da Trading Inc dba Wefun Inc
Brand name: WEFUN
Product recalled: Dietary Supplement with undeclared Sildenafil
Reason of the recall: Undeclared drug, Sildenafil
FDA Recall date: September 05, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wefun-inc-issues-voluntary-nationwide-recall-wefun-capsules-due-presence-undeclared-sildenafil