美国食品药品管理局召回ORL Labs约51762件牙膏与漱口水 检出孕酮等激素成分
美国食品药品管理局公布的召回信息显示，总部位于亚利桑那州Scottsdale的ORL Labs LLC正在全美召回约51,762件Organic Oral Care系列产品。抽样检测在部分产品中检出孕酮、雌二醇或脱氢表雄酮（DHEA），企业将原因归为交叉污染。
召回覆盖六款产品。三款牙膏均为4盎司装，包括Fresh Mint Natural Toothpaste 19,247件、Cinnamint Toothpaste 7,202件和Bubblegum Kids Natural Toothpaste 3,976件。三款漱口水均为16.9盎司装，包括Fresh Mint Mouthwash 12,081件、Cinnamint Kids Mouthwash 6,140件和Bubblegum Kids Mouthwash 3,116件。六款产品中三款面向儿童。受影响产品的有效期分布在2026年9月至2028年8月之间，消费者可按包装上的UPC条码与批次号核对。
食品药品管理局于11月6日将此次召回定为II级。按该局说明，II级召回指使用或接触相关产品可能造成暂时性或医学上可逆的健康后果，发生严重不良健康后果的可能性较低。截至召回公布时，尚未收到与受影响产品相关的患病报告。
该局表示，孕酮与雌二醇是用于部分避孕药与激素替代疗法的激素，DHEA是肾上腺自然产生的一种激素。持有受影响产品的消费者应核对包装信息，停止使用，并丢弃产品或向零售商询问退货处理。
FDA Recalls About 51,762 ORL Labs Toothpaste and Mouthwash Units After Hormone Contamination Detected
Recall information published by the U.S. Food and Drug Administration shows that ORL Labs LLC, based in Scottsdale, Arizona, is recalling approximately 51,762 units of its Organic Oral Care products nationwide. Sampling detected progesterone, estradiol or dehydroepiandrosterone (DHEA) in some products, and the company attributed the issue to cross-contamination.
The recall covers six products. The three toothpastes, all in 4-ounce tubes, are Fresh Mint Natural Toothpaste with 19,247 units, Cinnamint Toothpaste with 7,202 units and Bubblegum Kids Natural Toothpaste with 3,976 units. The three mouthwashes, all in 16.9-ounce bottles, are Fresh Mint Mouthwash with 12,081 units, Cinnamint Kids Mouthwash with 6,140 units and Bubblegum Kids Mouthwash with 3,116 units. Three of the six products are marketed for children. The affected products carry expiration dates ranging from September 2026 through August 2028, and consumers can check the UPC codes and lot numbers printed on the packaging.
The FDA classified the recall as Class II on November 6. Under the agency's description, a Class II recall means exposure may cause temporary or medically reversible health consequences, while the likelihood of serious adverse health consequences is considered remote. No illnesses had been reported in connection with the recalled products.
The agency said progesterone and estradiol are hormones used in certain contraceptives and hormone replacement therapies, while DHEA is a hormone naturally produced by the adrenal glands. Consumers who bought an affected product should check the packaging against the recall list, stop using it, and discard it or contact the retailer about a possible return.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：图：一把挤有牙膏的牙刷特写（资料图）。作者：William Warby，CC BY 2.0，维基共享资源。 / Photo: Close-up of a toothbrush with toothpaste (file photo). Credit: William Warby, CC BY 2.0, via Wikimedia Commons.
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