Manufacturer with Cork base recalls batches of infant formula due to toxin risk

Batches of infant formula and follow-on formula made in Ireland and distributed to the UK and EU are being recalled because of the potential presence of a toxin.

The Food Safety Authority of Ireland (FSAI) has advised the Irish public that Danone is recalling specific batches of its formulas because of the potential presence of cereulide.

Danone has manufacturing operations in Macroom and in Wexford.

The implicated products were manufactured in Ireland, but the FSAI said it had been notified by Danone that none of the implicated products have been distributed in the country.

However, the products have been exported to a number of EU countries, the UK and third countries.

The FSAI has notified the European Commission of this recall.

According to Danone Ireland, Macroom is one of the two biggest supply points in the Danone network and the first contingency supply point for fermented products.

Operating on a 24/7 basis, infant formula base powder is produced in Macroom and supplied to other supply points across the Danone network in Ireland, across Europe and further afield to China, Indonesia, Brazil and at Argentina for local markets as well as export.

Two well-known brands on sale in Ireland are Cow & Gate and Aptamil. They are produced in Macroom, finished and packaged in Wexford, before being supplied to markets all over the world.

An ingredient, ARA oil, which was manufactured in China, was contaminated with cereulide and added as an ingredient in base powder used to make infant formula and follow-on formula.

Cereulide is a toxin produced by some strains of the bacterium Bacillus cereus, which can cause food poisoning.

This recall is associated with a contaminated raw ingredient which was also implicated in the recent recall of some batches of infant formula and follow-on formula by Nestle in its SMA product line earlier this month.

The FSAI and the Department of Agriculture, Food and the Marine who regulate the Danone manufacturing facilities in Ireland, continue to engage with Danone to ensure that all food safety measures are being taken to protect consumers.

Danone said it “never compromises on food safety”.

In a statement, the company said: “In light of the current situation in the industry, some local food safety authorities are evolving their guidance.

“This is a targeted recall, mainly in Europe, of only a very limited number of specific batches of infant formula products.

“This does not impact any Danone products in the Irish market and our infant formula products can be purchased and used as normal.” 

It added: “As a responsible manufacturer, and to comply with the latest guidance, we have voluntarily recalled an isolated batch of Aptamil First Infant Milk in the UK. This affects batch number/expiry 31-10-2026, which was on shelf in the UK for approximately two weeks in July 2025.”