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FDA receives 18 reports of health concerns linked to recalled infant formula

The Food and Drug Administration (FDA) said it has received at least 18 reports involving health concerns linked to the consumption of recently recalled infant formula products.

The reports involve limited batches of Nan Optipro and Nankid Optipro, which were voluntarily recalled earlier this month by Nestlé Philippines.

In a statement, the FDA said that as of January 15, it had received a total of 25 reports associated with the recalled products, 18 of which involved health concerns observed by parents or caregivers after intake of the infant formula.

Reported symptoms include vomiting, diarrhea, abdominal pain, and other conditions, some of which required medical attention, the agency said.

On January 9, Nestlé Philippines announced the voluntary recall of limited batches of Nan Optipro and Nankid Optipro after detecting a possible quality issue. The company said only a small number of batches distributed in the Philippines were affected. Consumers may check whether their product is included in the recall by entering the batch number on the box or foil packaging through the company’s recall website.

Nestlé Philippines said the decision to recall the affected batches was made “out of an abundance of caution” and in line with its quality and safety protocols, adding that all other Nestlé products and unaffected batches of the same brands are not covered by the recall.

In a separate statement, Nestlé Philippines said it is working closely with the FDA to address the reported health concerns. The company said it has expanded its consumer care teams to respond to inquiries and is offering product replacement for recalled items, as well as access to teleconsultation services with healthcare professionals.

Parents and caregivers may contact Nestlé Philippines through its hotline, email, Facebook page, or website. The company also said it is coordinating with retail partners nationwide to ensure an efficient return and exchange process.

Nestlé Philippines further clarified that health authorities have not established specific food safety thresholds for the substance detected in the products, citing inconclusive scientific data directly linking exposure to adverse health effects. It said the recall was undertaken to avoid potential exposure and prioritize the well-being of infants and children.

Meanwhile, the FDA said all reported cases are subject to review to determine appropriate regulatory action. The agency said it continues to coordinate with Nestlé Philippines, which has been directed to submit regular updates on the implementation and progress of the voluntary recall.

The FDA added that established procedures remain in place for the receipt, assessment, and disposition of consumer complaints and reports of suspected adverse events, and that it continues to conduct post-market surveillance.

The agency said it understands the concerns of parents and caregivers and urged them to closely monitor the health of infants and young children. Those with concerns are advised to consult healthcare professionals and report related cases to the FDA through [email protected].

The FDA said it remains committed to safeguarding public health, particularly the safety of infants and young children, and will issue further updates as warranted based on verified findings and regulatory processes.

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