Ultimate Forza男性补充剂全批次召回：检出未标明的西地那非等三种处方药成分
美国食品药品监管局（FDA）10月24日发布召回公告：位于明尼苏达州 Lakeville 的 Tonight We Ride, LLC 公司自愿召回其 Ultimate Forza 男性补充剂胶囊的全部批次，召回至消费者层面。公告称，该产品被检出含有未在标签中标明的西地那非（sildenafil）、他达拉非（tadalafil）与达泊西汀（dapoxetine）。
公告指出，西地那非与他达拉非分别是 FDA 批准的处方药 Viagra 与 Cialis 的活性成分，只能在有执照的医疗专业人员监督下使用；这两种未标明成分可能与某些处方药中的硝酸盐类（如硝酸甘油）发生相互作用，把血压降到危险水平，而糖尿病、高血压、高胆固醇与心脏病患者经常服用硝酸盐类药物。达泊西汀则未获 FDA 在美国批准，其安全性与有效性未经确立；公告称，该成分属于选择性血清素再摄取抑制剂（SSRI）类药物，研究显示其摄入会增加儿童、青少年与年轻成人出现自杀想法与行为的风险。因含有这些成分，该产品被视为未经批准的药物。
此次召回涉及两个规格：十粒装的 Ultimate Forza Multi-Capsule/Box（货号 810208，UPC 868592000002）与单粒装的 Ultimate Forza Single Pack（货号 810222，UPC 868592000040），胶囊为蓝色硬壳。产品自2017年至2026年10月1日期间，经美国部分独立经营的 GNC 加盟店销售，未在 GNC 公司直营店出售。公告称，截至目前尚未收到与该产品相关的不良事件或投诉报告。
Ultimate Forza Male Supplement Recalled in Full: FDA Notice Finds Undeclared Sildenafil, Tadalafil and Dapoxetine
The U.S. Food and Drug Administration (FDA) published a recall announcement on October 24: Tonight We Ride, LLC, of Lakeville, Minnesota, is voluntarily recalling all lots of its Ultimate Forza Male Supplement capsules to the consumer level. The announcement says the product was found to contain undeclared sildenafil, tadalafil and dapoxetine.
Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, whose use is restricted to supervision by a licensed health care professional, the announcement notes. The undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels; people with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. Dapoxetine is not approved by the FDA in the United States, and its safety and efficacy have not been established; it belongs to the selective serotonin reuptake inhibitor (SSRI) class, and consumption has been shown to increase the risk of suicidal thinking and behavior in children, adolescents and young adults. The presence of the three ingredients renders the product an unapproved drug.
The recall covers the Ultimate Forza Multi-Capsule/Box (Item #810208, UPC 868592000002), containing ten blue hard-shell capsules, and the Ultimate Forza Single Pack (Item #810222, UPC 868592000040), containing one capsule. The products were distributed through certain independently owned and operated GNC franchise locations in the United States from 2017 to October 1, 2026, and were not sold through GNC corporate stores. No adverse events or complaints have been reported to date, according to the announcement.
来源：GSM·美国（原文链接）
图片来源：图：美国食品药品监管局（FDA）位于加州 Irvine 的办公楼（资料照片）。照片：Beyond My Ken 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / File photo: The U.S. Food and Drug Administration office building in Irvine, California. Photo by Beyond My Ken, CC BY-SA 4.0, via Wikimedia Commons.
