ByHeart Baby Formula Recall Amid Botulism Outbreak Investigation

In a developing public health concern, ByHeart has proactively recalled two specific batches of its Whole Nutrition Infant Formula. This measure comes amidst a broader inquiry by federal health authorities into a multi-state surge of infant botulism cases. Although a definitive causal relationship between the formula and the reported illnesses has yet to be established, ByHeart emphasizes its commitment to safety and transparency by taking this preventative step. Parents utilizing this formula are urged to inspect their product's batch codes and expiration dates to ensure their infants' well-being.

Urgent Infant Formula Recall Issued Following Botulism Investigation

On November 8, 2025, ByHeart, a prominent infant formula manufacturer, announced a voluntary recall of two particular batches of its Whole Nutrition Infant Formula. This action was taken in direct response to an ongoing investigation led by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The investigation commenced after the FDA alerted ByHeart on November 7, 2025, regarding a noticeable increase in infant botulism cases across various states. Out of 83 reported cases since August 2025, thirteen infants who had consumed ByHeart formula are under close scrutiny. These cases span ten states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

Infant botulism, while rare, is a severe condition that can be life-threatening. It manifests when infants ingest Clostridium botulinum spores, which then produce neurotoxins within their developing digestive systems. Symptoms can include constipation, difficulty feeding, drooping eyelids, diminished muscle tone, impaired sucking and swallowing, and a weak cry. Immediate medical attention is crucial, as untreated cases can progress to severe weakness and respiratory failure. While laboratory tests are still pending to confirm any direct correlation between the ByHeart formula and the botulism cases, the company has opted for a cautious approach, emphasizing that botulism is uncommonly associated with dairy products or infant formula, typically originating from environmental sources like soil.

Mia Funt, Co-Founder and President of ByHeart, stated that the company is treating this potential safety concern with the utmost seriousness, acknowledging the apprehension it may cause parents. The recalled batches are identified by Batch Code: 251261P2 and Batch Code: 251131P2, both with a 'Use by' date of December 1, 2026. Parents are strongly advised to check the lot numbers and expiration dates located at the bottom of their formula cans. Should these codes match the recalled batches, the product should be immediately discarded. Alternatively, affected formula can be returned to the point of purchase for a refund or exchanged directly with ByHeart by contacting them via email or phone at 1-833-429-4327. Parents observing any botulism symptoms in their infants are urged to contact their pediatrician without delay.

This incident underscores the critical importance of rigorous safety protocols and swift, transparent responses from manufacturers when potential health risks emerge in consumer products, especially those intended for vulnerable populations like infants. For parents, this serves as a potent reminder to remain vigilant about product recalls and to prioritize their child's health by consulting medical professionals for any signs of illness. The ongoing investigation highlights the complex nature of food safety and the collaborative efforts required from regulatory bodies, manufacturers, and the public to protect health.