More than 43 lakh tubes of toothpaste have been recalled across the United States, including several products marketed to children and featuring popular characters such as Barbie, Hot Wheels and My Little Pony.

The voluntary recall was initiated by India-based manufacturer Pritam International Private Limited on September 10, according to the US Food and Drug Administration (FDA). The agency classified the recall as Class II on October 19.

The FDA’s enforcement report lists 17 recalled toothpaste products, distributed by Ashtel Studios Inc., based in Ontario, California.

The FDA did not specify the exact reason for the recall. Its notice cited deviations from Current Good Manufacturing Practices, which are intended to ensure products meet required manufacturing and quality standards.
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Which toothpaste brands are affected?

The recall includes several varieties of Brush Buddies toothpaste, including children’s products featuring Barbie, Hot Wheels, Crayola and My Little Pony. Flavours include bubble gum, strawberry, watermelon, chocolate ice cream, vanilla ice cream and cookies ’n cream.

The recall also covers three other product varieties: one Brush Buddies whitening toothpaste, one cavity-protection toothpaste and one advanced-whitening toothpaste. In addition, two Evo products marketed for whitening and sensitivity and two ARU toothpastes marketed for gum health and cavity protection are included.

The recalled products come in 3.5-ounce and 4-ounce tubes, as well as a two-pack containing two 3.5-ounce tubes. The FDA notice lists expiration dates ranging from November 2026 to June 2028.

Consumers can check the FDA’s official recall notice for the affected product names, lot numbers and expiration dates.
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What does the FDA’s Class II recall mean?

The FDA classifies a recall as Class II when using or being exposed to an affected product may cause temporary or medically reversible health consequences, or when the likelihood of serious adverse health consequences is considered remote.

The agency did not identify a specific defect in the toothpaste or disclose a more detailed reason for the recall. The notice also did not report any illnesses or injuries linked to the products.

According to the agency, consumers should check whether their toothpaste matches the products, lot numbers and expiration dates listed in the FDA notice. Those who have an affected product should stop using it and contact the retailer or manufacturer for information about returns or refunds.

The recall covers products distributed nationwide in the US.