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The National Health Surveillance Agency (Anvisa) ordered the immediate recall of an infant formula sold in Brazil after identifying irregularities related to the product’s sanitary regulation. The measure also prohibits the commercialization, distribution, manufacturing, advertising, and use of the item throughout the national territory.
The information was disclosed by “Jornal Midiamax,” based on Resolution No. 2.302/2026 published in the Official Gazette of the Union (DOU) on June 9, 2026. According to Anvisa, the decision aims to protect the health of infants and young children, considered one of the most vulnerable groups from a nutritional and sanitary perspective.
The product affected by the determination is the 1st and 2nd Childhood infant formula from the brand Essentia Pharma, manufactured by HKM Farmácia de Manipulação Ltda., registered under CNPJ 06.354.562/0001-10.
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In addition to the mandatory recall, the health agency ordered the immediate cessation of any activity related to the product. Thus, manufacturers, distributors, retailers, and consumers must comply with the guidelines set out in the resolution.
Why Anvisa banned Essentia Pharma’s infant formula
According to Anvisa, the company was marketing the product without the necessary sanitary regulation for this type of food intended for children.
Furthermore, the agency identified that the labels, information, and claims on the packaging could lead consumers to believe that the product met the criteria required for a regulated infant formula.
However, the manufacturer did not provide proof that the product met the requirements related to safety, composition, quality, and nutritional value required by Brazilian legislation for foods intended for babies and young children.
For this reason, Anvisa concluded that the continued commercialization could pose health risks to consumers.
According to the agency, the situation could also mislead parents and guardians, creating the perception that the product had specific sanitary approval for infant use.
Health risks to infants and young children motivated decision
Nutrition in the early years of life requires rigorous care. Therefore, Brazilian legislation establishes specific criteria for infant formulas and products intended for early childhood.
In this context, Anvisa highlighted that infants and young children have specific nutritional needs and are more sensitive to possible failures related to food composition.
Moreover, any nutritional inadequacy can compromise the healthy development of this age group.
The agency emphasized that it found no evidence that Essentia Pharma’s infant formula met the standards required to ensure food safety for the child audience.
Consequently, the product’s presence in the market could expose vulnerable consumers to unnecessary risks.
For this reason, Anvisa decided to adopt a preventive and immediate measure to avoid potential impacts on children’s health.
What consumers and establishments should do now
After the publication of Resolution No. 2,302/2026 in the Official Gazette on June 9, 2026, the product is now prohibited from being sold nationwide.
Additionally, distributors, pharmacies, specialty stores, and other establishments must immediately remove the infant formula from their shelves.
Consumers who have units of the product should also stop using it and seek information directly from the manufacturer’s official channels or health surveillance agencies.
The measure applies to the 1st and 2nd Childhood infant formula of the Essentia Pharma brand manufactured by HKM Farmácia de Manipulação Ltda., registered under CNPJ 06.354.562/0001-10.
Anvisa emphasized that the decision aims to preserve child food safety and prevent products without adequate proof from continuing to be used by babies and young children.
With this, the agency seeks to ensure that only infant formulas that meet safety, quality, composition, and nutritional value requirements remain available for consumption in the Brazilian market.
