Teva Israel has announced a supplementary recall of one batch of Nutrilon AR baby formula products intended for infants suffering from acid reflux and spitting up on Friday.
The recall was issued following laboratory tests conducted at the Health Ministry's direction, after recall events around the world, which indicated toxin levels exceeding threshold values recently set by authorities in Ireland, and served as the basis for a risk assessment in Israel.
According to the Health Ministry, no unusual clinical manifestations or ongoing morbidity related to the toxins have been observed in Israel so far.
The recall is being carried out as a precautionary measure, and the public is asked to refrain from using the relevant products.
The announcement joins a previous recall carried out on January 24, 2026, a spot recall of one batch of 800-gram packages of Nutrilon Phase 1, batch number 2027.01.07, following concerns about the presence of the toxin cereulide.
Since the original recall, testing has been expanded to include more batches and Nutrilon AR in two different packages, both with the same batch number.
Identifying recalled products
Teva Israel announced that the newly released products are Nutrilon AR in 400-gram and 900-gram packages from batch number 2026.12.01 with an expiration date of 01.12.2026.
Teva Israel’s advisory to parents instructs: Do not feed babies products from this batch. Even if the package has been partially used, use should be stopped immediately and switched to an alternative formula that is not included in the recall.
Nutrilon AR is a formula specifically designed for babies who suffer from excessive vomiting and spitting up. Due to the fact that babies who consume Nitrilon AR are prone to vomiting, it is particularly important to distinguish between known symptoms of reflux and symptoms that may occur following exposure to the toxin.
The Health Ministry emphasizes that the continued use of the recalled products is not recommended, even if the baby appears to be in normal condition.
Cereulide toxin, cause for concern, and Health Ministry instructions
Cereulide is a toxin produced by certain strains of the bacteria Bacillus cereus. It is a particularly resistant toxin that is not destroyed by heat, reheating, or acidic conditions.
This means that even careful preparation of infant formula according to instructions, including boiling water and sterilizing bottles, does not guarantee that the toxin is killed if it has already formed in the product.
The bacteria themselves are very common in the environment and can be found in soil, dust, water, and food; in most cases, they do not cause a problem. The risk arises when conditions allow the production of toxins, such as cereulide.
Why is this a global recall and not a specific one?
Investigations conducted around the world revealed that the origin of the recall was a malfunction in the production of a raw material called arachidonic fatty acid, ARA, which serves as a central fatty component in baby formula compounds.
Conditions created during the production process allowed Bacillus cereus to thrive and accumulate the toxin cereulide.
Since the number of ARA manufacturers in the world is limited, the malfunction affected a number of formula manufacturers in various countries, and led to recalls by additional companies.
What does the deviation from the threshold values mean?
The limits set for safe levels of the toxin cereulide were recently updated by authorities in Ireland and served as the basis for necessitating risk assessment in Israel.
In Israel, as in many other countries, there is still no dedicated regulation for the toxin itself, and therefore, a particularly strict threshold was chosen.
The exceeding of the threshold value has not been proven to harm infants, but justifies the taking of immediate precautionary measures.
Can the toxin be neutralized at home?
The Health Ministry clarified that the toxin can not be destroyed by boiling water, heating, preparation according to the manufacturer's instructions, or sterilization. These actions are important for preventing other infections, but are not relevant to the breakdown of ceruloide.
What symptoms may occur in a baby exposed to the toxin?
Possible symptoms are not unique and include vomiting, diarrhea, abdominal pain, and cramps. In infants, this can manifest as continuous crying, restlessness, refusal to eat, and drowsiness.
In some cases, signs of dehydration may appear. The Health Ministry stated that symptoms usually appear within 30 minutes to 6 hours of consumption.
How long do symptoms last, and is exposure dangerous?
In most cases, symptoms resolve on their own within 6 to 24 hours.
However, when vomiting or diarrhea is excessive, prolonged, or severe, or when the baby seems lethargic or has difficulty drinking, medical evaluation should be sought as soon as possible. The main risk to infants is dehydration.
Is this a contagious condition?
Cereulide poisoning is not contagious and can not be passed from person to person. Exposure occurs only through the consumption of food that contains the toxin preformed in the product itself.
What can be done if a baby has consumed the recalled product?
If the baby is asymptomatic, the instruction is to discontinue use of the recalled product and switch to an alternative formula. Routine testing is not recommended in the absence of symptoms.
If repeated vomiting, diarrhea, unusual sleepiness, or signs of dehydration occur, parents should contact a doctor.
When should one urgently seek medical attention or go to the emergency room?
Urgent care is required when symptoms are severe or worsening, when there is persistent vomiting, excessive diarrhea, apathy, refusal to drink, or clear signs of dehydration. In young infants, the threshold for referral is particularly low.
How is cereulide poisoning diagnosed?
The diagnosis is based on the clinical evaluation and the time period between product consumption and the onset of symptoms. There is no specific laboratory test that confirms cereulide poisoning, so it is important to inform the doctor if a baby has consumed a product from the batch that was collected.
What is the treatment for cereulide exposure?
Treatment is only supportive and focuses on preventing dehydration and providing fluids as needed. Antibiotics are ineffective and not recommended because the poisoning is from a toxin and not an active bacterial infection.
What to do with recalled formula found in the home?
The product should not be used, and any formula prepared from it should be discarded. If symptoms appear after consumption, it is recommended to keep the package for testing, as necessary.
Is there a concern for long-term effects?
In most cases, a full recovery is expected. Serious cases are very rare, but the medical literature has described cases of liver damage and multi-system failure after exposure to extremely high levels of the toxin.
Is there a danger in formula products from other companies?
The Health Ministry reported that in tests conducted with importers and manufacturers, no indication was found that other Israeli companies used the suspected contaminated ingredients.
Continuous monitoring, sampling of additional products, and tightening of procedures as necessary is ongoing.
What is expected next?
An opinion from the European Food Safety Authority is expected to be published in the coming days. The Health Ministry continues to monitor the recall, demands a full investigation report and a plan to prevent recurrence from the importer, and will update the public according to further developments.