The U.S. Food and Drug Administration (FDA) is investigating an outbreak of a rare and potentially life-threatening illness — infant botulism — that may be linked to the consumption of an organic powdered infant formula, according to HealthDay.

The agency has identified three cases of infant botulism caused by botulinum toxin type A in three states: California, Pennsylvania, and Washington. All affected infants had consumed the same formula during April or May.

The product under investigation is Nara Organics Whole Milk Organic Powdered Infant Formula, which was sold nationwide through Target stores, Target.com, and the manufacturer’s official website.

According to investigators, the formula was distributed across the United States from July 2025 through June 2026 and was not sold outside the country.

Two package sizes are currently subject to the investigation and recall:

  • 700-gram package (UPC: 860013251901)

  • 400-gram package (UPC: 860013251918)

Infant botulism is a rare but serious condition in which Clostridium botulinum bacteria produce a toxin in a baby’s intestines. The illness can cause muscle weakness and severe neurological complications.

The FDA has not yet determined the exact source of contamination. However, all confirmed cases share one common factor: consumption of the same infant formula product.

The investigation remains ongoing as federal officials examine manufacturing processes and potential sources of contamination.