Lead Recall in 2022

The incident that changed NeoKare


In late 2022 random testing identified higher than acceptable levels of lead in the NeoKare MMF fortifier. NeoKare instigated a root cause analysis to determine the cause of that contamination, recalled the affected fortifier and as a precautionary measure, all unaffected products

The journey to resolving the lead contamination

Root cause analysis identified two factors that led to the unexpected high lead level.

  • 1 Malfunctioning piece of equipment, which transferred the metal into the processed milk

  • 2 The lead naturally present in human milk was concentrated during the manufacturing process.

The equipment causing the contamination was replaced and NeoKare reviewed its entire production line and initiated an enhanced quality control program which means all products are tested upon completion of processing.

Lead is invariably present in human milk. To minimise lead levels in the fortifier, NeoKare redesigned the manufacturing process. As a result of considerable research and development work, a new fortifier, HM18, was developed by mid-2023. This new product satisfies not only UK regulations for heavy metal content but also meets much more stringent EU regulations.

The company has learnt valuable lessons during this challenging period not just about operational issues or the interactions between lead and milk components, but also about enhanced quality procedures and better communication with health care professionals, regulatory authorities, and end users.

Our new quality control programme means that NeoKare is the only human milk-based fortifier manufacturer routinely testing all product batches for lead and arsenic contamination before market release. We trust that the introduced changes will reassure both clinicians and parents that NeoKare produces some of the safest products in the industry.