ByHeart Infant Formula has been recalled for possible botulism contamination. There is a botulism outbreak that has sickened 13 infants, according to the CDC, that may be associated with this product.
The case count of babies with suspected or confirmed infant botulism by state is: Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). Illness onset dates range from mid-August to November 2025. All 13 infants were treated with BabyBIG®. The infants range in age from 15 to 157 days old.
The company has stated, “The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.”
ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism reported nationwide since August 2025. Of these, 13 infants were fed ByHeart formula.
Mia Funt, Co-Founder and President of the company, said in a statement, “The safety and well-being of every infant who uses our formula is our absolute highest priority. We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
The recalled product is ByHeart Whole Nutrition Infant formula that is packaged in a 24 ounce can. The can is white with a blue lid. There is black printing on the can and various colored banners. The UPC number for the product is 5004496800. The batch codes and use by dates, which are stamped on the bottom of the can, are Batch Code: 251261P2, Use by: 01 Dec 2026 and Batch Code: 251131P2, Use by: 01 Dec 2026.
If you bought this infant formula, stop feeding it to your baby immediately. You can throw the formula away in a secure garbage can after first wrapping or double bagging it so others can’t see it, or you can take it back to the place of purchase for a refund. You can also contact the company and they will send another can of a different batch of the formula at no cost.
If you fed your baby this formula, watch carefully for the symptoms of botulism poisoning, which can include constipation, but is first usually noticed by parents as difficulty feeding (sucking and swallowing), a weak and different cry, loss of muscle tone, along with loss of head control and decreased facial expression. Any of these symptoms should prompt you to see a doctor immediately.
Botulism poisoning is a reportable condition, and your doctor will report it to public health officials. You can report it too, either by completing an electronic MedWatch form, or by calling an FDA Consumer Complaint Coordinator.
