US CDC Declares ByHeart Infant Botulism Outbreak Over After Dozens of Cases

Washington, DC — February 27, 2026

Parents across multiple states can breathe easier. Health officials have officially closed the books on a troubling outbreak of infant botulism tied to ByHeart powdered formula. The Centers for Disease Control and Prevention made the call on Thursday after tracking cases that hospitalized babies under one year old.

Background Infant botulism strikes young children when spores of Clostridium botulinum bacteria take hold in their immature digestive systems. Symptoms include weak cry, poor feeding, constipation, and muscle weakness that can lead to breathing trouble. Unlike foodborne botulism in adults, this form comes from spores germinating inside the body. Powdered infant formulas have faced scrutiny before because they aren't sterile like liquid versions.

What Happened The outbreak surfaced late last year when reports linked confirmed and probable cases to ByHeart's product. Federal investigators, working with state health departments and the FDA, identified 28 confirmed cases and 20 probable ones by February 26. Babies required intensive care in many instances, some needing ventilators. Authorities pulled affected batches from shelves and warned parents to stop using the formula.

Why It Matters For families relying on formula, any contamination risk shakes confidence in everyday essentials. Infants are especially vulnerable—botulism can progress fast and leave lasting effects if not caught early. The outbreak spanned multiple states, highlighting how quickly issues in one product can spread nationwide. Parents now face questions about safe alternatives while supply chains adjust.

Official Response CDC officials confirmed the outbreak is over. No new cases have appeared linked to the product in recent weeks. The agency stressed that investigations into the root cause continue. FDA representatives said they are examining manufacturing processes at ByHeart facilities. Health departments urged caregivers to watch for symptoms and seek immediate medical help if concerns arise.

Broader Context or Industry Impact This isn't the first formula-related scare. Past incidents with cronobacter and other bacteria prompted recalls and tighter regulations. The infant formula market remains tight after shortages in 2022-2023, so disruptions hit hard. Companies like ByHeart emphasize safety testing, but this case shows vulnerabilities persist. Pediatricians report increased calls from worried parents asking about formula choices and homemade options, which experts strongly discourage due to higher risks.

What Happens Next The ongoing probe could lead to new safety standards for powdered formula production. Regulators may push for enhanced spore testing or processing changes. ByHeart has cooperated fully, according to statements, and plans to resume full distribution once cleared. Families affected may pursue support through health programs. Public health teams continue monitoring for any related cases, even as the outbreak phase ends.

The declaration brings relief but serves as a reminder: infant nutrition carries high stakes. Officials urge vigilance without panic—most formulas remain safe when prepared correctly.