United States issues urgent warning to formula industry
PUBLISHED Jul 14, 2026, 12:42 PM ET
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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).
By Sarah Whitman | JQJO News
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
News Intelligence
- 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.
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