HEALTH

United States issues urgent warning to formula industry

▪

Read, Watch or Listen

The U.S. Food and Drug Administration on Monday, July 13, 2026, issued an urgent letter to the infant formula industry and its supply chain partners after back-to-back multistate infant botulism outbreaks linked to powdered formula. The letter, sent to manufacturers, packagers, distributors, exporters, importers and retailers, demands immediate, rigorous supplier oversight and heightened vigilance. Investigations conducted with the Centers for Disease Control and Prevention and state health authorities identified two affected brands, ByHeart, Inc. and Nara Organics, Inc., both of which initiated voluntary recalls. FDA inspections traced Clostridium botulinum contamination to organic whole milk powder supplied by Dairy West Milk (Organic West Milk).

Prepared by Olivia Bennett and reviewed by editorial team.

Timeline of Events

Nearly 50 years ago infant botulism first clinically characterized
2025 ByHeart-associated infant botulism outbreak confirmed
2025 FDA finds C. botulinum in milk powder
2025 Dairy West Milk identified as contaminated supplier
Jun 13, 2026 Nara Organics outbreak announced publicly
Mid 2026 Voluntary recalls by affected formula brands
Jul 13, 2026 FDA issues urgent industry-wide warning
Jul 2026 FDA urges stricter supplier oversight nationwide

Why This Matters to You

Your baby's health could be at risk if you're using ByHeart or Nara Organics formula. Check your pantry and return any recalled products. Be vigilant about formula safety, especially with powdered versions.

The Bottom Line

The FDA's warning underscores the need for strict oversight in the infant formula industry. Your baby's health is too important to risk. Share this with fellow parents who might be using these brands.