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Notification of a recall of a small number of human breast milk products

The Food Standards Agency (FSA) is working with Trading Standards to investigate how human breast milk products made by NeoKare Nutrition Limited contained elevated levels of lead. The Department of Health and Social Care, UK Health Security Agency, NHS England, Welsh Government, Public Health Wales, NHS Wales and Food Standards Scotland (FSS) are also supporting the FSA in their response.

Last updated: 6 January 2023
Last updated: 6 January 2023

The company sold a small number of human breast milk products to people online. Thirteen hospitals were also supplied by the company. Of those supplied, 7 hospitals used the product – 6 in England and 1 in Wales. One of the products was given by some hospitals to a small number of premature babies as part of a clinical trial or as an alternative source of nutrition.

On the advice of Trading Standards and the FSA, all the products sold by the company have been withdrawn and recalled by the business as a precaution. A small number of customers who purchased the affected products online have been notified by the company. 

The small number of families whose children had been given some of the affected products have been contacted by the NHS. The risk to the health of those who have been given these products is likely to be low. 

Only commercial products made by NeoKare Nutrition Limited are affected by the recall. No other human breast milk or baby formula products on sale to the public are included in the recall and donor human breast milk from not-for-profit milk banks is unaffected. 

Junior Johnson, Director of Operations at the Food Standards Agency said: 

‘This situation is understandably worrying for the parents and guardians affected. We have worked closely with the public health authorities and the NHS to assess the risk to health, which is likely to be low. 

‘Following advice from FSA and Trading Standards, the business recalled the products and we’ve ensured that customers and patients are contacted. Additional support has been offered to retail customers and to families whose children were given the products.

‘We continue to work with Trading Standards to ensure there is no further food safety risk to the public.’

The details of the products affected by the recalls are: 
•    MOTHER’S MILK FORTIFIER (MMF) POWDER 10 x 1g, food for special medical purpose, supplied to NHS Hospitals only for use predominantly in clinical trials involving preterm babies, not available for retail sale
•    PASTEURISED HUMAN BREAST MILK (PHBM) POWDER 6g (supplied direct to customers online)
•    70CAL LIQUID FROZEN 15ml and 50ml, (supplied to the NHS Hospitals and supplied direct to customers online)
•    PASTEURISED HUMAN BREAST MILK (PHBM) LIQUID FROZEN 50ml (supplied direct to customers online)

Lead is a metal that occurs naturally in the environment. It is present at low levels in many foods as a result of it being in soil and water. Everyone has a background exposure to lead from dietary sources because lead is present in food. Investigations are ongoing to establish how the elevated levels of lead occurred. 
There are no maximum levels for lead set in legislation for human breast milk. However, NeoKare Nutrition Limited’s Mother’s Milk Fortifier product is also classed as ‘food for special medical purposes’, which has to be given under medical supervision, and this product does have a maximum legal limit for lead.