Call our Parent Experience team at 1-866-201-9069 for all questions and concerns. We’re available 24/7. You can speak with a person live, or leave your number and we’ll call you back as soon as possible.

Orders placed on ByHeart.com on or after October 1, 2025 will be eligible to receive a refund. Please call us at 866-201-9069 and our team will assist you. We’re available 24/7.

• Customers will receive a refund of up to two units of ByHeart product—cans or Anywhere Packs. 
• First-time customers will receive a full refund on their first order, staying true to our ByHeart Promise. 

If you purchased ByHeart through one of our retail partners or Amazon, please contact the retailer directly and they will assist you with your refund options. 

Consumers who have purchased ByHeart Whole Nutrition Infant Formula, including cans and Anywhere Packs, should immediately discontinue use of the product. 

If your child develops symptoms your state health department might want to collect your formula container for testing. Keep the container in a safe spot and be sure to label that product as DO NOT USE. If your child does not develop symptoms after 30 days, throw your containers out. 

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. To report an illness or adverse event, you can:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem. 
• Complete an electronic Voluntary MedWatch form online. 
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

Infant botulism is the infectious form of botulism, which results when swallowed spores of a particular bacterium (Clostridium botulinum) colonize the baby's large intestine and produce botulinum toxin. 

According to the American Academy of Pediatrics, in infants, the illness often begins with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy. Symptoms of foodborne botulism typically appear within 12-48 hours after ingestion of the source of the bacterium, but according to the AAP, the incubation period for infant botulism can range from 3-30 days. If you think your baby is experiencing symptoms of infant botulism, please contact your medical provider immediately.

To report an illness or adverse event, you can:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem. 
• Complete an electronic Voluntary MedWatch form online. 
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

Infant botulism is treated with a combination of supportive care and a medication called an antitoxin. Please reach out to your medical provider immediately if you suspect your baby is experiencing symptoms of infant botulism.

A baby contracts infant botulism by swallowing the botulism spores at an age when their large intestine is vulnerable. It is not yet well understood what factors make an infant susceptible to activation of the spores. Ingestion of Clostridium Botulinum has been most commonly associated with honey, and for this reason honey is not a recommended food for infants under 12 months of age. According to testing conducted by the Infant Botulism Treatment and Prevention Program, most infants acquired the spores by swallowing dust particles that carry them, and in the majority of cases of infant botulism where the source of the bacterium was identified, soil or dust particles have been associated.

No, the Infant Botulism Treatment and Prevention Program reports there are typically no long-term effects from infant botulism. As long as there are no serious complications during the hospital stay, babies generally make a full and complete recovery, with no lasting health problems.

Out of an abundance of caution, we are recommending you sanitize any items or surfaces that may have come into contact with ByHeart formula. Wash bottles, preparation equipment, countertops, and utensils using hot soapy water or run them through the dishwasher.

For device/appliance specific use or cleaning instructions, such as Baby Brezza, contact the original manufacturer for guidance.

It’s important to practice proper bottle preparation. See below for a step by step guide.

1. Wash your hands and surfaces

• Wash hands with soap and water for at least 20 seconds.
• Clean and sanitize the preparation area.
• Make sure bottles, nipples, rings, and caps are clean or have been sanitized 

2. Follow formula instructions exactly

• Always read the label on your specific formula brand — measurements differ slightly by manufacturer.
• Use the provided scoop (not another brand’s scoop or household spoon).
• Add the correct amount of water first, then the powder (this ensures proper dilution).
• Cap the bottle and shake well until smooth — no clumps should remain.

In response to a broader FDA investigation of infant botulism in babies across the U.S., and out of an abundance of caution, we have decided to voluntarily recall all ByHeart formula nationwide—this includes both our cans and our single-serve Anywhere Pack™ sticks. 

ByHeart was notified by the FDA on Nov 7, 2025 that an estimated 85 cases of infant botulism were reported nationwide since August 2025. Of these, 13 babies had received ByHeart formula at some point. Within 24 hours, we voluntarily recalled the initially identified batches. On Nov 11, 2025, we expanded the recall to include all batches nationwide.  

It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. Your baby’s safety is, and always will be, our biggest priority.

Out of an abundance of caution, we are voluntarily recalling all ByHeart formula nationwide—this includes both our cans and our single-serve Anywhere Pack™ sticks.

We do not have detailed information at this time whether other infant formula brands have been impacted by the FDA’s investigation. The FDA is the appropriate source for updates on other infant formula brands.