约430万支牙膏被召回：FDA定为二级召回，Barbie、Hot Wheels等儿童品牌在列
美国食品药品监督管理局（FDA）在10月19日发布的执法报告中，将一批含氟防蛀牙膏的召回定为二级（Class II）召回，事件编号99849。此次召回由生产商 Pritam International Private Limited 于9月10日发起，该公司位于印度 Haridwar，美国经销商为 Ashtel Studios Inc.，包装上标注的地址位于加州 Ontario。召回原因是产品生产过程不符合现行药品生产质量管理规范（CGMP）。
被召回的共有17款产品，涉及 Brush Buddies、evo 与 ARU 三个品牌，在全美范围内销售，总量约430万支。其中面向儿童的产品包括 Brush Buddies 的 Barbie 泡泡糖味牙膏（约40.98万支）、Hot Wheels 草莓味牙膏（约41.16万支）、Crayola Silly Scents 三种口味牙膏（每种口味约32.02万支）与 My Little Pony 牙膏（约1.74万支）；其余为 evo 美白与抗敏感牙膏、四种冰淇淋口味牙膏、小苏打美白牙膏、BB 防蛀双支装、BB 美白牙膏以及 ARU 牙龈健康与防蛀牙膏等成人产品。
按 FDA 的分级标准，二级召回指使用或接触被召回产品可能造成暂时性或医学上可逆的不良健康后果，发生严重健康后果的可能性较低。FDA 此次没有就该召回另发新闻稿，全部受影响产品的名称、批号与有效期列在执法报告中，所列批次的有效期自2026年12月至2028年年中不等，消费者可按包装上的批号与 FDA 执法报告的清单核对。
About 4.3 Million Toothpaste Tubes Recalled: FDA Classifies the Recall as Class II, With Barbie and Hot Wheels Children's Brands Listed
In its enforcement report released October 19, the U.S. Food and Drug Administration (FDA) classified a recall of anticavity fluoride toothpastes as a Class II recall, under event number 99849. The recall was initiated on September 10 by the manufacturer, Pritam International Private Limited of Haridwar, India, whose U.S. distributor is Ashtel Studios Inc., listed on the packaging at an address in Ontario, California. The stated reason is that the products were made under conditions that deviated from current good manufacturing practice (CGMP) requirements.
The recall covers 17 products under the Brush Buddies, evo and ARU brands, sold nationwide in the United States, totaling about 4.3 million tubes. Children's products on the list include Brush Buddies Barbie bubble gum toothpaste (about 409,800 tubes), Hot Wheels strawberry toothpaste (about 411,600 tubes), Crayola Silly Scents toothpaste in three flavors (about 320,232 tubes per flavor) and My Little Pony toothpaste (about 17,400 tubes). The remaining products are adult toothpastes, including evo whitening and sensitive formulas, four ice-cream-flavored varieties, a whitening toothpaste with baking soda, BB cavity protection two-packs, BB advanced whitening, and ARU gum health and cavity protection toothpastes.
Under the FDA's classification system, a Class II recall is a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is remote. The FDA issued no separate press release for this recall; the names, lot numbers and expiration dates of all affected products are listed in the enforcement report, with listed lots carrying expiration dates from December 2026 through mid-2028, against which consumers can check the lot numbers printed on their packaging.
发布：GSM·美国（发布链接）
图片来源：图：刷牙资料图（非涉事产品）。Bill Branson 摄，公共领域，经 Wikimedia Commons。
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