The Food and Drug Administration has announced a fourth infant has been hospitalized with botulism after consuming Nara Organics Powdered Infant Formula,

“Parents and Caregivers should stop using Nara Organics Whole Milk Organic Infant Formula immediately,” the FDA said Monday, adding that the agency is actively investigating the outbreak affecting infants in California, Pennsylvania and Washington. 

The FDA also advised parents to keep any opened cans in case the child develops botulism and the FDA needs to test them.

Botulism is caused by the ingestion of Clostridium botulinum, a neurotoxin-producing bacteria often found in improperly stored or preserved foods, honey, and the environment. 

In infants, symptoms include muscle weakness, drooping eyelids, difficulty swallowing or breathing. And if untreated, the ingestion could lead to paralysis and-or death. 

In coordination with the Center for Disease Control and the Infant Botulism Treatment and Prevention Program (IBTPP), the FDA has collected unopened samples from implicated formula lot numbers for testing, with results expected in the coming weeks. 

Separately, state officials collected opened formula cans from sick infants' homes, and CDPH testing detected Clostridium botulinum in an opened can of Nara Organics powdered infant formula from one affected infant's home.

Nara Organics Powdered Infant Formula follows ByHeart Whole Nutrition Infant Formula, recalled in late 2025 after causing 28 confirmed and 20 probable cases of botulism in children under the age of 1.  

Critics blame the FDA for failing to recall the formula sooner, citing insufficient oversight due to recent staffing cuts by President Trump. 

However, the Trump administration, which has previously defended staffing cuts across federal agencies to reduce waste and bureaucratic bloating, reported increased recalls in 2025 compared to those under Biden in 2024.