A major baby formula brand, ByHeart, has announced a voluntary recall of two batches of its product following a nationwide investigation into cases of infant botulism. This decision, made on November 8, 2025, comes after the U.S. Food and Drug Administration (FDA) alerted the company to a concerning outbreak. Since August 2025, approximately 83 cases of infant botulism have been reported across the United States, with 13 of those infants having consumed ByHeart formula.
In an official statement, ByHeart emphasized that the FDA has not found a direct link between their formula and the reported cases of infant botulism, nor have any toxins been detected in their products. Nevertheless, the company chose to act decisively, stating, “We decided to take this step to remove any potential risk from the market and ensure that the safety and well-being of every baby who uses ByHeart—including our own—will always come first.”
Details of the Recall
The recall affects two specific batches of the ByHeart Whole Nutrition Infant Formula. The details are as follows:
– **Batch Code:** 251261P2, **Use by:** December 1, 2026
– **Batch Code:** 251131P2, **Use by:** December 1, 2026
Both batches carry the UPC code 5004496800, which can be located on the bottom of the formula cans. These products are sold online and at major retailers across the country. Currently, no other batches of ByHeart’s infant formula are implicated in this recall.
Understanding Infant Botulism
Infant botulism is a rare but severe illness caused by a toxin that affects the body’s nervous system. According to the Centers for Disease Control and Prevention (CDC), the condition is primarily linked to the bacteria Clostridium botulinum, which can produce toxins in food, infants’ intestines, and wounds.
In certain conditions, these bacteria can grow and release a lethal toxin. Factors that create a conducive environment for this growth include:
– Sufficient moisture
– Specific temperature ranges
– Low acidity
– Low or no oxygen
– Low salt and sugar levels
Symptoms of infant botulism include constipation, diminished feeding reflexes, drooping eyelids, and respiratory difficulties. If left untreated, the condition can become life-threatening.
Current Outbreak and Consumer Guidance
The FDA and CDC are investigating the multi-state outbreak in collaboration with the California Department of Public Health and local partners. As of the latest update on November 8, 2025, 13 infants across ten states—Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington—have been hospitalized due to confirmed or suspected cases of infant botulism. All affected infants had been given the recalled ByHeart formula.
Consumers who have purchased the affected formula should stop using the product immediately and dispose of it. ByHeart has stated that it will replace any discarded cans from the impacted batches at no cost. Parents are advised to seek medical attention promptly if their infant exhibits symptoms of botulism. For any adverse reactions or illnesses, consumers should report their concerns to an FDA Consumer Complaint Coordinator or fill out a Voluntary MedWatch form.
For further assistance, customers can contact ByHeart directly at [email protected] or by calling 1 (833) 429-4327.
