Health ministry launches probe into death of infant who consumed recalled formula

The Health Ministry is investigating what led to the death of a 4-week-old who was fed baby formula that had been subjected to a nationwide recall.

The baby died from respiratory failure on Friday after being rushed to Samson Assuta Ashdod Hospital. The same day, the Health Ministry expanded a recall of Nutrilon formula, which had previously been issued for specific batches of the product.

An autopsy by the Abu Kabir National Institute of Forensic Medicine found no clinical link between the formula consumption and the infant’s death, but it has mandated additional testing, the Health Ministry said Thursday.

It is also probing why the baby’s death was not reported to government officials in a timely manner, the ministry said. It was not immediately clear when the death was reported.

The investigation is being carried out by an external committee composed of experts across relevant medical fields, according to a ministry statement, which pledged “full transparency as the investigation proceeds toward its final conclusions.”

A spokesperson for the Ashdod hospital said the infant had been rushed to the pediatric emergency department of the hospital in severe respiratory distress.

A senior medical team specializing in pediatric intensive care “fought for the infant’s life, following all accepted professional standards and performing prolonged resuscitation efforts,” the hospital said.

A preliminary investigation following the death revealed that the baby had been given Nutrilon formula.

The death came a week after the ministry issued a recall of three batches of Nutrilon AR and Nutrilon Stage 1 formula.

The January 30 recall was issued in cooperation with the importer, Teva Israel Ltd., which had received reports from the manufacturer in Europe regarding concerns that the formula could contain an ingredient with elevated levels of cereulide, a toxin produced by the bacterium Bacillus cereus.

On February 6, the ministry expanded the recall to include any Nutrilon AR or Stage 1 formula, including from unaffected batches, as a preventative measure. There is no indication that the expanded recall was issued in reaction to the baby’s death.

Nestle and Danone, the maker of Nutrilon, initially began recalling infant formula in December and January across Europe and Asia after discovering cereulide in ingredients supplied by a vendor in China.

According to the Health Ministry, the elevated levels of cereulide had been found in arachidonic acid, or ARA, supplied by a specific vendor.

On February 2, the European food safety body issued new guidance regarding the threshold for cereulide, prompting additional recalls, including the expanded action in Israel on February 6.

Cereulide can cause sudden nausea, vomiting and stomach pain 30 minutes to six hours after ingestion.

In younger infants, it can change the body’s salt balance and lead to complications such as dehydration. The possible negative health effects are considered low to moderate and depend on the infant’s age, with infants under six months more at risk of severe disease.

At the time of the ministry’s recall, it emphasized that the vast majority of the affected batch had not yet reached the retail market and only a limited number of units were actually sold to the public.

It is clarified that other Nutrilon products marketed in Israel did not use the ARA from the suspected supplier.

Infant formula often includes oils containing the ARA fatty acid to make it resemble breast milk. Bacillus cereus spores can survive in dry ingredients used for infant formula and, under certain conditions during ingredient handling or processing, may grow and produce cereulide.

Because the toxin is heat-stable, heat treatment will not destroy it, allowing it to remain in the finished formula.

On Wednesday, French authorities said they were investigating the death of a third baby who had consumed infant formula covered by the precautionary recalls, after previously announcing probes into two other infants who died after consuming formula recalled by Nestle’s Guigoz brand.

“To date, no causal link has been scientifically established. Judicial investigations are in progress,” the French Health Ministry said.

The incident raised harrowing memories in Israel of a previous traumatic infant formula failure.

In  2003, three infants died and some 20 were left with severe disabilities after consuming non-dairy formula from batches of the Israeli-marketed brand Remedia The formula completely lacked Vitamin B1, which is essential for the nervous system.

Reuters contributed to this report.