The US Food and Drug Administration (FDA) and US Centers for Disease Control and Prevention (CDC) and state and local public health authorities are investigating a new outbreak of three cases of infant botulism linked to powdered infant formula.

The FDA was alerted to the outbreak by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP).

The affected infants are in California, Pennsylvania, and Washington. They range in age from 3-5 months old.

All three infants have been hospitalized and were treated with the anti-botulinum treatment, BabyBIG.

The three infants were fed Nara Organics Whole Milk Organic Infant Formula, a powdered infant formula. The implicated product was manufactured in Germany, and sold in the United States across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. The powdered milk product was not distributed outside of the USA.

Officials in two of the states that reported illnesses have collected leftover powdered formula for testing. Federal and state officials also are collecting and testing unopened cans of product.

Nara Organics has recalled all of their Nara Organics brand Whole Milk Organic Powdered Infant Formula (400g & 700g; Lot codes 408125075E14F2, 708125076E14F2, 708125083E14F2, 408125139E14F2, 708125141E14F2, 708125145E14F2, 708125174E14F2, 709125273E14F2, 709125280E14F2, 709125288E14F2, 409125307E14F2, 70926019ENNB, 70926029ENNB, 70926035ENNB, 70926039ENNB, and 70926042ENNB).

The FDA urges parents and caregivers to stop use of Nara Organics Whole Milk Organic Infant Formula immediately. If your child is experiencing symptoms (see below) after consuming Nara Organics Whole Milk Organic Infant Formula. If you still have the formula in your home, please record/take a picture of the information on the container before throwing it away. Alternatively, store the leftover powdered formula (clearly labeled “DO NOT USE”) in a safe place in case the state health authorities wish to collect it for testing.

Symptoms of infant botulism may include constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. These symptoms can take as long as several weeks to develop following formula ingestion.

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.