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.
Published by GSM · USA (original Chinese edition)
Photo: 图：刷牙资料图（非涉事产品）。Bill Branson 摄，公共领域，经 Wikimedia Commons。
