Company recalls supplement over undeclared sildenafil presence

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Martin A. Makary Commissioner of Food and Drugs - Food and Drug Administration | U.S. Food and Drug Administration

Company recalls supplement over undeclared sildenafil presence

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EnShiShiXiangNiShangMaoYouXianGongSi has announced a voluntary recall of its ENDURANCE BOOST WITH HORNY GOAT WEED capsules due to the presence of undeclared substances, specifically Propoxyphenylsildenafil and Sildenafil. These substances are typically used in FDA-approved drugs for treating male erectile dysfunction and are not permitted in dietary supplements. The product, marketed as a nutritional supplement for male performance and energy, is an unapproved new drug with unverified safety and efficacy.

The recall was initiated after regular sampling revealed the contamination. According to the company, "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." The primary risk group includes adult males who use nitrates for cardiac conditions.

To date, no adverse events related to this recall have been reported by EnShiShiXiangNiShangMaoYouXianGongSi. The affected product is packaged in blue and white cartons containing 20-count blister packs. It was distributed online through US Amazon.com, identified by LOT: 250214PRO with an expiration date of February 14, 2027.

The company is notifying customers through this announcement and coordinating the return of all recalled products. Consumers are advised to stop using the product if they possess it and consult their healthcare provider if any issues arise from its use. Returns should be sent to 150-67 Northern Blvd, Flushing, NY 11354.

For inquiries regarding the recall, consumers can contact EnShiShiXiangNiShangMaoYouXianGongSi via email at nutriservice2025@outlook.com during business hours from Monday to Friday. Additionally, adverse reactions or quality problems can be reported to the FDA's MedWatch Adverse Event Reporting program online or by mail or fax.

This recall is conducted under the supervision of the U.S. Food and Drug Administration.

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