The recall covers 17 products, including Brush Buddies children’s varieties featuring Barbie, Hot Wheels, Crayola and My Little Pony branding.
WASHINGTON — More than 4.3 million tubes of toothpaste sold across the United States are being recalled after federal regulators cited deviations from current good manufacturing practices, affecting 17 children’s and adult toothpaste products distributed nationwide.
The recall includes multiple Brush Buddies toothpastes marketed to children, along with evo whitening and sensitivity products and ARU gum health and cavity-protection toothpaste. Pritam International Private Limited, an India-based manufacturer, initiated the voluntary recall Sept. 10. The products were distributed in the United States by Ashtel Studios Inc. of Ontario, California. The Food and Drug Administration later classified the action as a Class II recall.
The affected Brush Buddies products include character-themed toothpaste carrying Barbie, Hot Wheels, Crayola Silly Scents and My Little Pony branding. Flavors include bubble gum, strawberry and watermelon. Other Brush Buddies products in the recall include vanilla ice cream, mint chocolate chip ice cream, cookies ’n cream and chocolate ice cream varieties, as well as whitening and cavity-protection formulas.
The recall also covers evo Advanced Whitening Anticavity Fluoride Toothpaste in peppermint flavor and evo Sensitive Anticavity Fluoride Toothpaste in sweet mint. Two ARU products are included: Gum Health toothpaste in soothing mint and Cavity Protection toothpaste in cool mint. Products were sold in 3.5-ounce and 4-ounce tubes, while one Brush Buddies cavity-protection product was packaged as a two-pack of 3.5-ounce tubes.
Federal records list the reason for the recall as deviations from current good manufacturing practice requirements. Those regulations govern how drug products are manufactured, processed and packaged and are intended to help ensure that products meet standards for identity, strength, quality and purity. The FDA has not publicly detailed the specific manufacturing problems that led to the toothpaste recall.
The FDA classified the recall as Class II, a category used when exposure to a product may cause temporary or medically reversible adverse health consequences or when the likelihood of serious health effects is considered remote. Published reports reviewing the federal recall information said no illnesses or injuries had been reported in connection with the toothpaste at the time of the announcement.
The recall affects about 4.3 million individual tubes. The largest quantity among the listed products is Brush Buddies Whitening Anticavity Fluoride Toothpaste with Baking Soda in cool mint, with nearly 798,000 tubes included. The Hot Wheels strawberry toothpaste accounts for more than 411,000 tubes, while the Barbie bubble gum variety accounts for nearly 410,000. Three Crayola Silly Scents varieties together account for more than 960,000 tubes.
Only specified lots are included in the recall, meaning not every tube sold under the affected brand names is necessarily subject to the action. Federal recall records identify individual lot numbers and expiration dates for the products. The affected expiration dates reported in the federal records extend from late 2026 into 2028, depending on the product and lot.
The recall has drawn particular attention because many of the affected products are designed for children and feature widely recognized toys and characters on their packaging. The list nevertheless extends beyond children’s toothpaste to whitening, sensitivity, gum-health and general cavity-protection products intended for broader use. All of the recalled products were distributed nationwide.
The FDA had not announced a specific contaminant or other individual defect associated with the recalled toothpaste as of the latest reports. The recall remained listed as a Class II action, and consumers seeking to determine whether a tube is affected can compare its product name, lot code and expiration date with the federal enforcement record.
Author note: Last updated October 24, 2026.