Recall of infant formula, EleCare, Similac and Alimentum, due to potential microbial contamination

What is the issue?

EleCare, Similac and Alimentum infant formula products manufactured in United States are subject to a precautionary recall.

The recall is due to potential microbial contamination with Salmonella Newport (Salmonella) or Cronobacter sakazakii (Cronobacter).

In Victoria, the products are available through prescription at pharmacies, hospitals and via direct mail order.

Alternative products are available. It is important that use of the recalled product does not cease until an appropriate alternative is identified and sourced. Advice should be sought from a treating medical professional or pharmacist.

The recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package. Products are included in the recall if they have all three items below:

• the first two digits of the code are 22 through 37, and;
• the code on the container contains K8, SH, or Z2, and;
• the expiration date is 1 April 2022 (APR 2022) or later.

See photos of batch codes:

Who is at risk?

Infants and young children who consume EleCare, Similac and Alimentum infant formula products. The products are predominately for babies 0-12 months but can be used by older children with allergies as well.

Product information

EleCare is PBS Authority listed for eosinophilic oesophagitis; cows' milk protein enteropathy; severe cows' milk protein enteropathy with failure to thrive; combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein; cows' milk anaphylaxis; cows' milk protein enteropathy; severe intestinal malabsorption including short bowel syndrome.

EleCare LCP is PBS Authority listed for cows’ milk protein enteropathy; combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein; cows' milk anaphylaxis; cows' milk protein enteropathy; severe intestinal malabsorption including short bowel syndrome.

See Pharmaceutical Benefits Scheme (PBS) website for details of PBS Authority listings and where specialist PBS Authority prescriptions are required for PBS subsidy.

Symptoms and transmission

Food products contaminated with Salmonella or Cronobacter may cause illness if consumed.

Salmonella infection can present with diarrhoea, vomiting, and fever. It can also cause bacteraemia and focal infections (e.g. bone and joint). Symptoms typically occur 12-72 hours after ingesting the contaminated food.

Cronobacter infection in infants can present with fever, accompanied by poor feeding, crying, or very low energy. Cronobacter infection can cause severe blood infections (sepsis) or meningitis and can be fatal in infants. Infants less than 2 months of age, those born prematurely or immunocompromised are at higher risk of Cronobacter infection.

Recommendations

The following measures are recommended to parents/ carers and medical professionals:

• Change to a suitable alternative product as soon as possible.
• Cease feeding the affected product once an alternative has been sourced.
• Anyone concerned about their baby’s symptoms should consult their doctor for advice without delay.
• All medical professionals should treat the patient according to clinical presentation and seek paediatric or neonatal advice as required.
• Treating physicians should be alert for clinical presentations related to this food recall and potential infection. If an infant presents with signs of bacterial gastroenterological infection; isolate, collect faeces for microscopy culture and sensitivity (MC&S) and blood for pathology. Forward positive results for Salmonella and Cronobacter to the Microbiological Diagnostic Unit (MDU) for further identification and sequencing.
• Medical advice on alternative products is recommended. Alternative products that may be recommended by doctors or pharmacists are detailed below.
• Community pharmacists are asked to assist parents/carers to identify and source suitable alternative formula products.
• Parents and carers can also enter the product lot code on the company’s website to check if it is part of the recall.
• Parents/carers may return the recalled product to the place of purchase for a full refund once an alternative product has been sourced.

There are a number of alternative products to EleCare, for infants under 12 months, and infants over 12 months.

See the Australasian Society of Clinical Immunology and Allergy Guide for Milk Substitutes in Cow’s Milk Allergy

Contacts

For more information, please contact Food Safety on 1300 364 352.

Subscribe now!

Keep informed of emergencies affecting the health sector and critical public health issues impacting your work.

Subscribe now to information including Chief Health Officer alerts and advisories from the Department of Health.

Follow the Chief Health Officer on Twitter