The U.S. Food and Drug Administration (FDA) has issued an urgent advisory regarding a voluntary recall of all Nara Organics whole milk organic powdered formula products due to potential contamination with infant botulism.
The potential contamination with Clostridium botulinum bacteria resulted in three infants across the U.S. contracting infant botulism and being hospitalized after being fed Nara Organics Whole Milk Infant Formula.
Infants may develop symptoms, including constipation, poor feeding, loss of head control, difficulty swallowing, droopy eyelids, slow pupils, diminished reflexes and facial expression, and breathing difficulties. Infant botulism can take weeks to develop after ingesting Clostridium botulinum bacteria, making tracing timelines vital to diagnosis and treatment of the illness.
Immediate Recommendations for Families:
- Stop Use Immediately: Families using this specific formula should discontinue it right away and discard any remaining product.
- Monitor Closely: If a child has consumed this product, caregivers should watch closely for symptoms of infant botulism.
- Seek Emergency Care: If an infant shows any signs of illness, caregivers should seek emergency medical care immediately rather than waiting for a formal diagnosis.
This alert comes just a few weeks after the FDA published their Executive Summary on the ByHeart recall that infected over 40 babies with botulism. From the summary:
Even though there are several hypotheses, investigational findings could not identify the source or root cause of contamination of the powdered infant formula.
As noted by the Radical Mom’s Union, “it’s pretty scary that even with the full scrutiny of the federal government there are no answers to the outbreak. That leaves parents in the lurch and allows companies to continue policing themselves. And remember, this ByHeart recall was unprecedented because up until 2025 botulism in baby formula was not a concern! Companies weren’t required to test for it. Now, here we are again.”