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2h ago

More Than 4 Million Toothpaste Tubes Recalled Nationwide

The FDA says Current Good Manufacturing Practice violations prompted a Class II recall that signals possible product quality problems or temporary health effects.

More than 4.3 million tubes of toothpaste are included in a nationwide recall involving children’s and adult products, according to an FDA Enforcement Report. (Photo by Ian Forsyth/Getty Images)
More than 4.3 million tubes of toothpaste are included in a nationwide recall involving children’s and adult products, according to an FDA Enforcement Report. (Photo by Ian Forsyth/Getty Images)
Baby brushing teeth with blue toothbrush
More than 4.3 million tubes of toothpaste are included in a nationwide recall involving children’s and adult products, according to an FDA Enforcement Report. (Photo by Ian Forsyth/Getty Images)

Overview

  • Pritam International Private Limited voluntarily launched the recall on Sept. 10 and federal enforcement reporting in mid- to late-October elevated it to a Class II action under FDA rules.
  • The recall covers more than four million tubes, with several outlets reporting about 4.3 million units across Brush Buddies, Evo and ARU product lines.
  • More than half of the recalled tubes are Brush Buddies children’s toothpastes featuring licensed characters such as Barbie, Hot Wheels, My Little Pony and Crayola.
  • Consumers should check National Drug Codes, lot numbers and FDA enforcement notices for exact affected lots and follow manufacturer or retailer instructions for returns or disposal.
  • Because fluoride toothpaste is regulated as an over-the-counter drug, the CGMP finding raises questions about manufacturing, testing or labeling processes and could prompt further agency review or corrective steps.