- Company Announcement Date:
- August 25, 2023
- FDA Publish Date:
- September 05, 2023
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason Description
Undeclared drug, Sildenafil
- Company Name:
- WEFUN Inc.
- Brand Name:
- Product Description:
Dietary Supplement with undeclared Sildenafil
FOR IMMEDIATE RELEASE – 08/25/2023 – Brooklyn, New York, 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.
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. WEFUN Inc has not received any reports of adverse events related to this recall.
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. The WEFUN Capsules was distributed Nationwide in the USA via internet sales via amazon.com and eshoponlineusa.com.
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.
Consumers with questions regarding this recall can contact WEFUN Inc by phone at 929-509-7343 7 Days a week from 9am-7pm Eastern Time, or e-mail address [email protected]. 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.
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.