The affected batch (100547289) contained 3,400 cans.
The company said the overall risk posed by the error was “low”, but the decision to recall the batch was made to protect children with conditions like maple syrup urine disease (MSUD).
MSUB is an inherited disorder in which the body is unable to properly process certain protein building blocks like amino acids making them "particularly sensitive" to increases in certain macronutrients.
The affected batches also posed a risk for children with Chylothorax, a rare condition that requires restricted fat intakes.
Nutricia said in a statement the issue was “isolated” and no other Seravit batches or other products were affected.
“This recall is being conducted as a precaution as there could be a potential for adverse effects for certain patient groups. Patient protection is of the utmost importance to Nutricia and we take any potential safety risk extremely seriously,” it said.
Paediatric Seravit is a Food for Special Medical Purposes (FSMP) containing vitamins, minerals and trace elements, which can be consumed as a drink or paste from birth.
To be used under medical supervision only, the product is designed for children with restrictive therapeutic diets because of inborn errors of metabolism such as Phenylketonuria (PKU) and MSUD as well as ‘elimination diets’ as a component of a modular feed.
After the issue was discovered, the company said it “promptly conducted an extensive safety risk assessment” with its food safety and toxicology teams.
“We have informed the relevant health authorities across all affected markets. Product quality and consumer safety is of the utmost importance to us, so please rest assured that we are taking all necessary steps to limit the likelihood of such quality issues occurring in the future,” it said in its statement.
Although the company did not respond to our questions on how the issue arose, it said it had now implemented extra sample points for release testing and would be reviewing its manufacturing critical control points (CCPs) and release testing protocols.