Excessive levels of lead have been found in 27,000 of the Imaginarium brand 213 piece Wooden Colouring Case.
The product has been on sale in Toys R Us stores across the US since October last year.
The violation specifically refers to the black watercolour paint in the set as well as the ink on the outer packaging of the wooden case.
Consumers are urged to return the cases to any Toys R Us store for credit.
The major retail outlet has also recalled the Priddy Books “Trucks” Cloth Shaker Teether because small pieces from the teether can break off and pose a chocking hazard.
No injuries have been reported.