FDA Issues Class I Recall of Endurance Supplement Tainted With Sildenafil

The US Food and Drug Administration (FDA) has announced a Class I recall of Endurance Boost with Horny Goat Weed following the discovery that the product contains undeclared pharmaceutical ingredients—sildenafil and propoxyphenylsildenafil, a structural analogue of sildenafil. The supplement, marketed as a 500 mg energy and endurance booster in 20-count cartons (UPC: X004BB9Z8N), was sold nationwide through the Amazon platform. The affected lot is 250214PRO, with an expiration date of February 14, 2027.

This recall, designated D-0453-2025 under event ID 96833, was voluntarily initiated by Chinese firm EnShiShiXiangNiShangMaoYouXianGongSi on May 6, 2025, and is currently ongoing. A public press release was issued to inform consumers and retailers. The FDA classifies this as the most serious type of recall—Class I—because use of the product could lead to serious adverse health consequences, particularly among individuals with underlying medical conditions or those taking nitrate medications.

While marketed as a dietary supplement, the presence of active pharmaceutical ingredients not disclosed on the label reclassifies the product as an unapproved drug. Sildenafil is used to treat erectile dysfunction, and its presence may pose significant risks, especially when combined with other medications. Pharmacists should be aware of the potential for patient harm and ensure removal of this product from any accessible inventory or platforms.