On November 8th, 2025, infant formula manufacturer ByHeart initiated a voluntary recall of two batches of ByHeart Whole Nutrition Infant Formula following an FDA investigation into an outbreak of infant botulism.
The company was notified on November 7th of an estimated 83 cases of infant botulism reported nationwide since August 2025. At least 13 of these infants were fed ByHeart Whole Nutrition Infant Formula.
While ByHeart and the FDA maintain that the voluntary recall was made out of an abundance of caution, it is of little solace to parents and families of affected infants. Botulism is a serious health threat and can be fatal, especially in such young patients. Studies have even shown that botulism may cause lifelong damaging effects in patients even after they recover from the initial illness.
If your child was fed ByHeart Whole Nutrition Infant Formula and contracted a Botulism infection, you deserve answers and justice. At Hill Law Firm, our attorneys are monitoring the situation as it evolves and stand ready to fight for the families of young victims.
Please, call us at (210) 960-3939 for a free and confidential consultation.
Products Affected by the Formula Recall
As of November 10th, the recall applies to two batches of ByHeart Whole Nutrition Infant Formula:
Certain batches of ByHeart Whole Nutrition Infant Formula:
- Batch Code: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Batch Code: 206VABP/251131P2 (“Use by 01 Dec 2026”)
The batch code and “Use by” date are located on the bottom of the infant formula can. The FDA has directed consumers who have purchased any formula from these two batches to discontinue use and dispose of the product immediately. If you did purchase formula from a contaminated batch, it may be in your best interest to document the date of purchase, save receipts, and take photographs of the cans.
Symptoms of Infant Botulism
Infant botulism is a medical emergency. If your child has consumed ByHeart formula – even if it was from a batch that was not recalled – and is showing any signs of botulism, seek immediate medical care. Early treatment can make a significant difference in their medical outcome.
The most common symptoms of infant botulism are:
- Muscle weakness, especially at the top of their body and limbs and keeps them from reaching and grabbing
- Poor feeding, such as weaker suck and choking while feeding
- Weaker crying
- Loss of head control
- Lack of facial expressions
- Difficulty swallowing
- Eyelid drooping
- Constipation and other bowel movement changes
It is extremely important that you understand and can recognize potential signs of trouble, as babies cannot tell you their symptoms. Most often, infants with botulism will not have a fever and seem well outside these symptoms.
About Infant Botulism
Infants can get botulism after eating something containing spores from the Clostridium botulinum bacteria – in this case, ByHeart Infant Formula. These spores enter the digestive tract, return to their bacterial form, and start releasing toxins. According to the World Health Organization, Botulism toxins can be extremely lethal.
Infants are, unfortunately, extremely susceptible to infection as they lack the natural defenses within their intestines to prevent bacterial germination and growth. If left untreated, botulism can lead to progressive paralysis, respiratory failure, and death.
Previous Recalls of ByHeart Infant Formulas
Unfortunately, this is not the first time that a ByHeart product has been recalled due to bacterial contamination. In 2022, ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months was recalled for cross-contamination of Cronobacter sakazakii. During a subsequent investigation, FDA investigators found significant regulatory violations for infant formula manufacturing, quality control, and record-keeping.
The FDA also found issues with the initial corrective action submitted by ByHeart, indicating that there were still issues left unaddressed.
If ByHeart was negligent at some point in their manufacturing process, they may be responsible for the illnesses and damages that their products cause.
Contact Hill Law Firm For Answers
If your family was affected by contaminated ByHeart Whole Nutrition Infant Formula, you deserve answers. Our attorneys understand how serious this issue is and the law surrounding food contamination. Let us fight for your child. Call (210) 960-3939 or fill out our contact form today.
Frequently Asked Questions
Why was ByHeart Formula Recalled?
Two batches of ByHeart infant formula were recalled as a result of an FDA investigation into botulism contamination.
What should I do if I suspect that my baby has contracted botulism?
Seek immediate medical attention. Botulism is a medical emergency. If you have any suspicions or your infant is displaying botulism symptoms, do not hesitate.
My baby was hospitalized with Botulism after being fed contaminated formula. What do I do next?
Continue to follow any medical or treatment instructions by your health care provider. If you are able to, save receipts proving the purchase of contaminated formula and the batch number as well as all medical bills and communication. Then speak with an attorney to fully understand your legal options. The investigation is ongoing and may continue to involve.