FDA: 18 reports involving 'health concerns' received on recalled infant formula products

The Food and Drug Administration (FDA) on Friday said it has received at least 18 reports involving “health concerns” due to intake of recently recalled infant formula products. 

The specific products are Nan Optipro and Nankid Optipro, limited batches of which were recently recalled by Nestlé Philippines. 

In a statement, the FDA said that as of January 15, 2026, it received 25 reports associated with the recalled products.

“Eighteen of these reports involve health concerns observed by parents or caregivers following consumption of the subject infant formula,” the agency said.

“Reported symptoms include vomiting, diarrhea, abdominal pain, and other conditions, some of which required medical attention,” it said.

On Jan. 9, Nestlé Philippines announced it is recalling limited batches of its infant formula products, Nan Optipro and Nankid Optipro, due to the detection of a possible quality issue. 

Nestlé Philippines assured that only a small number of batches in the Philippines were affected. Consumers can check if the item they bought is affected by the recall by inputting the batch number found on the box and foil packaging on this website: https://www.parenteam.com.ph/voluntary-precautionary-recall

The company said it has “decided to voluntarily recall the affected batches out of an abundance of caution and in line with its strict product quality and safety protocols,” adding that all other Nestlé products and other batches of the same brands are not in scope of the voluntary recall.

Closely working with FDA

In a statement on Sunday, Nestlé Philippines said it is working closely with the FDA in addressing the reported health concerns involving the recalled infant formula products.

“To affected families, we are here to help. We have significantly expanded our consumer care teams to respond promptly to inquiries,” Nestlé Philippines said.

“We are offering direct support, including product replacement for recalled products, and access to teleconsultation services with healthcare professionals for medical-related questions,” it added.

The company said parents and caregivers may contact them via hotline +632 9898 0001; email consumer.services@ph.nestle.com; Facebook or website.

Nestlé Philippines also said it is coordinating with its retail partners “to ensure an efficient return and exchange process nationwide.”

It also clarified that health authorities have not established a specific food safety threshold for the substance found in their infant formula products.

“It is important to clarify that health authorities have not established specific food safety thresholds for this substance, as available scientific data remain inconclusive in directly linking exposure to health effects,” Nestlé Philippines said.

“In the absence of defined safety and regulatory limits, we acted on scientific recommendations to avoid exposure and to prioritize the well-being of infants and children - making the decision to recall in favor of strict safety measures,” it added.

FDA to conduct review

The FDA, meanwhile, said that all reports it received are subject to review to “determine the appropriate regulatory actions.”

“Each report is evaluated, and - when necessary - the FDA coordinates with relevant agencies and offices to ensure proper handling verification, and resolution of the reported concerns,” the agency said.

The food and drugs regulator added that it "continues to maintain close regulatory coordination with the Market Authorization Holder, Nestlé Philippines Inc., which has been directed to submit regular and timely status reports on the implementation, assessment, and progress of the voluntary recall.”

“Established procedures remain in place for the receipt, documentation, assessment, and appropriate disposition of consumer complaints, including reports of suspected adverse events,” the FDA said.

“The FDA continues to exercise regulatory oversight of the recall through the review of information submitted by relevant parties and the conduct of post-market surveillance,” it added.

Moreover, the agency said that it understands the concerns of parents and caregivers and encourages them to continue closely caring for and observing the well-being of their infants and young children.

“Should there be any concerns about a child's health, seeking advice from a healthcare professional is encouraged. To help the FDA monitor the situation and provide appropriate assistance, parents and caregivers may also report any related concerns through ereport@fda.gov.ph,” it said.

“The FDA remains committed to safeguarding public health, particularly the health and safety of infants and young children. Further information will be communicated as warranted, consistent with verified findings and established regulatory processes,” it added. —with a report from Mariel Celine Serquiña/KG, GMA Integrated News