Endurance Boost Dietary supplement for male performance and energy recall: Undeclared Propoxyphenylsildenafil, Sildenafil

What the company announced

EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE BOOST WITH HORNY GOAT WEED (20 Count) capsules to the consumer level. During the regular sampling, the product has been found to be tainted with Propoxyphenylsildenafil (a sildenafil analogue) and Sildenafil. Sildenafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil cannot be marketed as dietary supplements. ENDURANCE BOOST WITH HORNY GOAT WEED is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumption of products with undeclared sildenafil and its analogue propoxyphenylsildenafil, 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. To date April 30, 2025, EnShiShiXiangNiShangMaoYouXianGongSi has not received any reports of adverse events related to this recall.

This tainted product is marketed as a nutrition supplement for male performance and energy, and is packaged in a blue and white cardboard carton, with white and black lettering and contains a 20-count blister pack. The affected lot is LOT: 250214PRO, Expiration Date: 02/14/2027. The product can be identified by the labels attached below. Product was distributed solely online at US Amazon.com.

EnShiShiXiangNiShangMaoYouXianGongSi is notifying its customers by this press announcement and is arranging for return of all recalled products. Please send all returns to 150-67 Northern Blvd, Flushing, NY 11354. Consumers that have capsules with lot number 250214PRO, Exp Date 02/14/2027, should stop using the product. 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.

Consumers with questions regarding this recall can contact EnShiShiXiangNiShangMaoYouXianGongSi by e-mail address： [email protected] (Available Monday-Friday 9AM-5PM PST). 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.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.