ByHeart has expanded its recall to include all batches of its Whole Nutrition Infant Formula and Anywhere Pack due to potential contamination with Clostridium botulinum, as announced by the Food and Drug Administration (FDA). This decision comes amidst a broader investigation into a notable increase in infant botulism cases, with 84 reported instances starting in August 2023. Although no unopened ByHeart products have tested positive for the spores or toxins associated with botulism, the company is taking precautionary measures.
The FDA, alongside the Centers for Disease Control and Prevention (CDC), is actively testing and monitoring for any signs of contamination. ByHeart is cooperating fully, engaging an independent third-party laboratory to conduct comprehensive testing of its formula. The recall specifically affects products identified by the can UPC 85004496800 and the Anywhere Pack UPC 85004496802.
Infant botulism, while rare, is a severe condition that occurs when spores of Clostridium botulinum are ingested and proliferate in the intestines, producing neurotoxins. Symptoms can include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, and respiratory difficulties. In some cases, it can lead to respiratory arrest. Parents are urged to seek immediate medical attention if their infant shows signs of these symptoms.
Consumers who have purchased the affected products should dispose of them immediately. For those needing to report an illness or adverse event, the FDA provides several avenues for communication, including calling their consumer complaint coordinator or completing a Voluntary MedWatch form online. ByHeart can also be contacted directly at [email protected] or via their hotline, available 24/7 at 833-429-4327.
In addition to the FDA’s efforts, the USDA offers resources for food safety questions and recalls. Their meat and poultry hotline, available at 888-674-6854, can assist with inquiries during business hours.
As the situation develops, ByHeart and regulatory bodies continue to prioritize consumer safety, ensuring that all necessary precautions are taken to protect infants from this potentially life-threatening condition.