Alfamino FAQs – HCP

Alfamino is now back in stock and available to recommend and prescribe.

Alfamino stock levels are now back to pre-recall levels.

Samples will be available to order via your sales representative. A communication will be sent out to everyone that has a sample service account when Alfamino samples become available again.

No. The Alfamino formulation remains unchanged. The amino acid profile, nutrient composition, clinical design, taste profile, and Halal certification are all identical to the pre-recall products. The recall was not related to formulation.

No. Preparation, dilution, and handling instructions remain exactly the same as shown on the product label.

We have discontinued sourcing the ingredient from the affected supplier and all batches of the ingredient (from other suppliers) are now being systematically tested to confirm the absence of cereulide.

We are also strengthening our testing processes, expanding them so that every single batch containing the ingredient is now tested for cereulide before it is used in our infant and follow‑on formulas.

These additional safeguards are designed to further strengthen our processes and help ensure you can continue to trust our products with confidence.

Yes. We have discontinued sourcing the ingredient from the affected supplier and all batches of the ingredient (from other suppliers) are now being systematically tested to confirm the absence of cereulide.

Yes. Every ARA batch from every supplier now undergoes pre-use cereulideuse cereulide testing.

Line sampling results confirmed the presence of very low levels of cereulide in a single production run of non-distributed infant formula produced at one of our manufacturing sites in Europe. This triggered further investigations to determine the root cause of this microbiological deviation and to determine the extent of the issue. This led to our precautionary voluntary recall.

Through national regulatory recall notices, official Nestlé Health Science communications Consumer Recall Notice UK | Nestlé Health Science and Consumer Recall Notice Ireland | Nestlé Health Science

Yes. Out of an abundance of caution, Nestlé made the decision to immediately initiate a voluntary recall on a precautionary basis.

It is reassuring to see that other companies are now following our lead to take action in light of the information we provided.

I’m afraid we are unable to comment on any other manufacturers. I would suggest you reach out to them directly if you’d like further information, as they would be best placed to advise.

In parallel, our teams are working hard to minimize any potential supply disruption.  

Nestlé remains committed to keeping parents, caregivers and the public informed, and to providing clear, transparent information and support throughout this process.

Commonly found in raw materials and occasionally in foods, such as milk and dairy products, Bacillus cereus is a microorganism most strains of which have no impact on food safety. It does, however, have the potential to create toxins, one of which is cereulide which can cause foodborne illness.

We detected very low levels of cereulide, attributable to an ingredient from a supplier an ARA (arachidonic acid-rich) oil, used in some of our formula products. While the amount of oil used in the products concerned is very low, we took the precautionary measure to proactively and voluntarily recall all potentially implicated batches in line with our strict product and safety protocols.

Furthermore, all product batches now being distributed from our formula manufacturing sites are undergoing enhanced quality and safety testing prior to their release. We have discontinued sourcing the ingredient from the affected supplier and all batches of the ingredient (from other suppliers) are now being systematically tested to confirm the absence of cereulide. 

Our zero tolerance approach led us to recall all infant formula batches that could theoretically contain cereulide due to the toxin’s presence in the ARA oil. ARA represents only a small proportion of the overall infant formula recipe, we applied the strictest possible approach, ensuring consumer safety is our absolute priority. This approach led us to recall all infant formula batches that could theoretically contain cereulide due to the toxin’s presence in the ARA oil. ARA represents only a small proportion of the overall infant formula recipe, we applied the strictest possible measure, ensuring consumer safety is our absolute priority.

Line sampling results confirmed the presence of very low levels of cereulide in a single production run of non-distributed infant formula produced at one of our manufacturing sites in Europe. This triggered further investigations to determine the root cause of this microbiological deviation and to determine the extent of the issue.

Following in-depth investigations, the cause of the issue has been identified as being a non-compliant ingredient from a supplier. It involves arachidonic acid-rich (ARA) oil, a polyunsaturated fatty acid that is used in some infant formulas and follow-on formulas and which plays a vital role in brain development, immune function, and overall cellular growth. Specific batches of ARA oil used in the products concerned have been found to deviate from expected quality standards.

We know that it’s important that you feel confident in the products you use for your baby.

In this situation, we recently found that one of the ingredients supplied to us was not of the right quality and did not meet the standards we require.

We’ve already taken a number of immediate steps. We have discontinued sourcing the ingredient from the affected supplier and all batches of the ingredient (from other suppliers) are now being systematically tested to confirm the absence of cereulide. 

We are also strengthening our testing processes, expanding them so that every single batch containing the ingredient is now tested for cereulide before it is used in our infant formulas.

These additional safeguards are designed to further strengthen our processes and help ensure you can continue to trust our products with confidence.

No, Althéra was not impacted.  It does not contain ARA from the supplier identified to be the source of the cereulide issue.

Yes, only the specified batches of SMA are affected. All other products are safe to consume.

This voluntary recall is a precautionary measure being performed out of an abundance of caution in line with our strict product quality and safety protocols and in full cooperation with the local authorities.

Infants and children who previously tolerated Alfamino can switch back as soon as the products are available again, where clinically appropriate. The switch‑back should be conducted under the supervision of their healthcare professionals, and parents should obtain a new prescription/recommendation. This means the return to Alfamino is properly documented in the child’s medical records.

For infants or young children who previously tolerated Alfamino, no issues are expected when switching back. Depending on the temporary replacement formula used, there may be a slight, temporary change in stool consistency or color, which is not harmful and will resolve quickly. This is due to differences in the recipe design of the products.

Parents can be reassured that Alfamino now benefits from strengthened global quality and safety controls. After the event, Nestlé permanently removed the implicated ARA supplier and introduced systematic cereulide testing of every ARA batch before use, going beyond regulatory requirements. These reinforced measures ensure that only batches meeting the highest safety standards enter the market.

It is also important to emphasise that the formulation has not changed. The amino‑acid profile, nutritional composition, clinical design, and taste profile remain exactly the same, and the recall was precautionary, not driven by any confirmed illness attributed to cereulide, or formulation issues.

Families returning to Alfamino can expect the same excellent tolerance and clinical benefits as before, consistent with their previous experience with the product.

Yes. The safety of our products and the wellbeing of infants is our highest priority.

No other Nestlé products are affected and remain safe to consume. All of our infant formula on the market is safe for babies.