A brand of human breast milk products has been recalled in the United Kingdom because of the level of lead.

NeoKare Nutrition has withdrawn and recalled all products. However, most items are already out of date.

The firm sold human breast milk to people online. Of 13 hospitals supplied by the company, seven used the product – six in England and one in Wales. One product was given by some hospitals to premature babies as part of a clinical trial or as an alternative source of nutrition.

The Food Standards Agency (FSA) and Trading Standards are trying to find out how the elevated levels of lead occurred. Lead is a metal that is found naturally in the environment and is present at low levels in foods as a result of it being in soil and water.

The Department of Health and Social Care, UK Health Security Agency (UKHSA), NHS England, Welsh Government, Public Health Wales, NHS Wales, and Food Standards Scotland (FSS) are also involved in the investigation.

Risk assessment and continued testing
The FSA, UKHSA, and the NHS have conducted a risk assessment which found the levels and duration of use of these products vary. Exposure to lead from them is likely to have been for a short period of time. Adverse effects from lead typically arise from repeated exposure over an extended period, so the risk to children has been assessed to be low.

Authorities are conducting tests on raw milk, pooled milk, and finished products to gather data to help understand the amounts of lead present. There are no maximum levels of lead in human breast milk. 

Junior Johnson, director of operations at the FSA, said the risk to health is likely to be low. 

“This situation is understandably worrying for the parents and guardians affected. 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,” he said.

The recall covers pasteurized human breast milk powder 6-gram and pasteurized human breast milk liquid frozen 50-milliliter sold to customers online.

Mother’s milk fortifier powder 10 x 1 gram is a food for special medical purposes and was supplied to NHS hospitals only for use in clinical trials involving preterm babies. 70Cal liquid frozen 15 milliliters and 50 milliliters was supplied to NHS hospitals and direct to customers online.

NeoKare advised people with the affected products to not feed them to their babies.

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

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