Consumers warned vs imported infant formula

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December 8, 2025 | 12:00am

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against the purchase and consumption of an imported infant formula linked to a rare illness.

According to the FDA, the United States Food and Drug Administration (US-FDA) is investigating an outbreak of infant botulism associated with ByHeart whole nutrition infant formula.

In an advisory, the US?FDA recalled all lots of ByHeart powdered infant formula, including 24-ounce cans and 0.6-ounce single?serve anywhere pack sticks, due to potential contamination with Clostridium botulinum spores.

According to the US-FDA, infant botulism occurs when Clostridium botulinum spores germinate and release toxins in the intestines of infants, mostly under six months of age.

Symptoms of the disease affecting the nervous system may include constipation, loss of appetite, weakness and a striking loss of head control.

The FDA noted that ByHeart whole nutrition infant formula is not a registered processed food product in the Philippines.

“It is not authorized for importation, distribution or sale in the country,” the agency said.

Surveillance and collaboration with authorities, the FDA said, is being undertaken to prevent the unauthorized entry of the unregistered infant formula.

The FDA reminded health care professionals to be on alert for symptoms of infant botulism and report suspected cases to the agency.