An Indian company is voluntarily recalling more than 4 million tubes of toothpaste sold nationwide in the United States, federal regulators announced this week.
The recall applies to 17 varieties of toothpaste, according to the US Food and Drug Administration’s enforcement report. Pritam International Private Limited initiated the recall because of Current Good Manufacturing Practice deviations.
“CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities,” according to the FDA. “Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.”
What Brands Are Affected?
The recall covers several children’s brands, including Brush Buddies, Barbie, Hot Wheels, My Little Pony, and Crayola Silly Scents. Adult brands include evo Advanced Whitening and Sensitive, BB Cavity Protection and Advanced Whitening, and ARU Gum Health and Cavity Protection.
The recalled products were sold in 4.0 oz and 3.5 oz tubes with various flavors, including bubble gum, strawberry, watermelon, peppermint, sweet mint, and even ice cream flavors like vanilla, mint chocolate chip, cookies ‘n cream, and chocolate.
The Classification
The FDA designated the recall a Class II, meaning there is a remote probability that using the products will cause serious adverse health consequences. Class II recalls are the second-most serious category, used when a product may cause temporary or medically reversible health problems.
The recall was initiated because of deviations from CGMP requirements, which are designed to ensure that products are consistently produced and controlled according to quality standards.
What Consumers Should Do
Consumers who have purchased any of the recalled toothpaste varieties should stop using them immediately and check the lot numbers and expiration dates listed in the FDA’s enforcement report.
The products were sold nationwide. Anyone with questions about the recall should contact Pritam International or the FDA.
The Bottom Line
Pritam International has recalled more than 4 million tubes of toothpaste sold nationwide in the US, including children’s brands like Barbie, Hot Wheels, and Crayola. The FDA classified the recall as Class II, meaning there is a remote probability of serious health consequences. The recall was triggered by manufacturing practice deviations. Consumers should check their toothpaste against the FDA’s recall list and stop using any affected products.
