In a significant development affecting parents across India and the United States, ByHeart has announced a nationwide voluntary recall of all its Whole Nutrition infant formula products. This decisive action comes amid growing concerns about infant botulism cases reported in multiple states.
Recall Details and Product Information
The recall, announced on Tuesday, encompasses all batches of ByHeart Whole Nutrition Infant Formula, including both cans and single-serve Anywhere Pack containers. The company took this precautionary measure despite no unopened products testing positive for Clostridium botulinum spores or toxins.
According to the official announcement, the voluntary recall specifically applies to two batches with the following details:
- Batch Code: 251261P2, Use by: 01 Dec 2026
- Batch Code: 251131P2, Use by: 01 Dec 2026
The affected products include cans with UPC 85004496800 and Anywhere Pack™ with UPC 85004496802. Consumers can locate the batch code and use-by date on the bottom of the can.
FDA Investigation and Company Response
The recall expansion follows intensive discussions between ByHeart and the U.S. Food and Drug Administration (FDA). On November 7, 2025, the FDA notified ByHeart about approximately 83 cases of infant botulism reported nationwide since August 2025. Among these cases, 13 infants had consumed ByHeart formula at some point.
In a heartfelt statement, ByHeart co-founders Mia Funt and Ron Belldegrun explained their decision: "We're writing to you today to tell you that we have decided to voluntarily recall all ByHeart formula nationwide. This decision was made to ensure your baby's safety."
The founders emphasized that neither the company, FDA, nor CDC found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. However, the discovery of two additional infant botulism cases in babies who had consumed ByHeart prompted the comprehensive recall.
What Parents Need to Know and Do
Immediate action is crucial for parents who have purchased the affected products. ByHeart strongly advises consumers to immediately discontinue use and properly dispose of any formula from the recalled batches.
The company has committed to replacing all affected cans at no cost, even for consumers who have already discarded the products. ByHeart's Parent Experience team is available to assist with questions and replacement procedures.
It's important to note that no other ByHeart batches or products are affected by this voluntary recall. The company maintains that this is a precautionary measure taken in close collaboration with federal health authorities.
Understanding Infant Botulism Risks
Infant botulism represents a rare but serious health threat to babies. According to World Health Organization definitions, infant botulism is an intoxication usually caused by ingestion of potent neurotoxins formed in contaminated foods.
Federal health officials have confirmed that while several infants have fallen sick across 12 states since August, no deaths have been reported in connection with these cases. The FDA continues its ongoing investigation into the infant botulism outbreak.
Health authorities emphasize that there is no historical precedent of infant formula causing infant botulism, and no direct link has been established between any specific infant formula and the reported cases. ByHeart's recall represents a proactive approach to eliminate any potential risk and ensure maximum safety for infants.
