ByHeart Baby Formula Recall
Summary:
– Defective baby formula ByHeart causing dangerous botulism
– At least 15 infants have been hospitalized
– Details on product recall
– Learn more about botulism
– Do you have a legal case?
What Are the Details about the Baby Formula Recall?
ByHeart Inc. issued a recall of two batches of its ByHeart Whole Nutrition Infant Formula after receiving notice from the U.S. Food and Drug Administration of an ongoing investigation into an infant botulism outbreak on November 8, 2025.
On November 11, 2025, ByHeart, Inc. expanded its voluntary recall to include all batches of ByHeart Whole Nutrition Formula and Anywhere Pack products.
To date, almost 20 infants in 12 states have been hospitalized after consuming ByHeart infant formula products.
The voluntary recall now applies to all batches of ByHeart Whole Nutrition Infant Formula cans and all Anywhere Packs:
Can UPC: 85004496800
Anywhere Pack UPC: 85004496802
Batch Code: 251261P2
Batch Code: 251131P2
According to information by California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Among them, 36 (43%) had any powdered infant formula exposure. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.
This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.
CDC, public health officials in several states, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and the U.S. Food and Drug Administration, are investigating a multistate outbreak of infant botulism linked to infant formula.
The company sells about 200,000 cans of infant formula a month online and in stores such as Target, Walmart, Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical officer at ByHeart.
Parents and caregivers who have the formula in their homes “should immediately discontinue use and dispose of the product,” Kuehn said.
If your baby consumed ByHeart infant formula and was diagnosed with infant botulism or another illness, you may be able to recover significant compensation for your damages.
You should immediately contact an experienced product liability lawyer to evaluate your claim.
ByHeart Recalled all of its Baby Formula Products
Infant formula is the sole source of nutrition for many infants. Parents choose infant formula carefully, often based on recommendations by their pediatrician, and expect it to be manufactured with the highest standards of safety.
Infant formula contaminated with bacteria can cause vulnerable babies to become seriously ill or even die. Infants should only consume nutrition that is pure and free of dangerous pathogens.
If your baby has become sick after consuming ByHeart infant formula, you should seek immediate medical attention. You should also promptly consult an experienced product liability lawyer to understand your rights.
At Chris and Frank Accident, our dangerous product lawyers have decades of experience and have secured millions of dollars in compensation for our clients.
Call 800-799-1044 or use our contact page for a free consultation to discuss your claim.
Which Infant Formula Products Have Been Recalled?
All ByHeart Whole Nutrition Infant Formula products have been recalled nationwide. The recalled formula was sold between August 2025 and November 2025 online through the company’s website and at major retailers throughout the United States, including:
- Amazon
- Target
- Walmart
- Kroger
- Albertsons
- Whole Foods
If you have any recalled product in your home or possession, stop using it immediately.
Why Were ByHeart Infant Formula Products Recalled?
ByHeart infant formula is linked to a multistate outbreak of infant botulism that began in August 2025. Botulism is a serious illness caused by the bacterium Clostridium botulinum. This bacterium produces a toxin in the infant’s intestines after consuming the contaminated formula.
Almost 20 infants aged 16 days to 5 months have been hospitalized after consuming the ByHeart formula.
To date, the affected infants have been located in the following twelve states:
Arizona
California
Colorado
Illinois
Kansas
Minnesota
New Jersey
Oregon
Pennsylvania
Rhode Island
Texas
Washington
During its initial investigation, the FDA noted that the ByHeart formula was “disproportionately represented among sick infants” in the botulism outbreak, even though this brand of formula only accounts for about 1% of all infant formula sold in the United States.
Symptoms of Infant Botulism
Botulism typically affects fewer than 200 babies in the United States each year. Symptoms of infant botulism include:
Constipation
Poor feeding and difficulty sucking or swallowing
Weak or altered cry
Drooping eyelids
Decreased facial expression
Loss of head control due to muscle weakness
Weak muscle tone
Difficulty breathing
Irritability
Drooling
Tiredness
Paralysis
Infant botulism is a medical emergency requiring immediate hospitalization. If left untreated, it could lead to paralysis and death.
What if You have the Recalled ByHeart Infant Formula?
If you have any of the recalled product in your possession, immediately stop using it. Even if your baby does not show any symptoms of illness, do not continue to use the formula.
You should also wash and sanitize all bottles, nipples, and surfaces that may have been in contact with the recalled formula.
If your baby has consumed ByHeart formula and has any signs of illness, you should seek immediate medical care. Symptoms of botulism can take several weeks to appear. So you should remain watchful for any signs of illness.
What to Do If ByHeart Formula Has Injured Your Baby
If your baby consumed ByHeart infant formula and was diagnosed with infant botulism or another illness, you may be able to recover significant compensation for your damages. You should immediately contact an experienced product liability lawyer to evaluate your claim.
Retain any evidence of your baby’s illness and their consumption of the recalled formula, such as receipts and any remaining product.
Contact Chris and Frank Today
Contaminated infant formula can cause devastating harm to infants. If ByHeart infant formula or any other defective product injured your child, you need an attorney who can hold the manufacturers accountable.
At Chris and Frank Accident Attorneys, our product liability lawyers have the experience, skills, and resources to help secure maximum compensation for your family. Let us help you.
Call 800-799-1044 or use our contact page for a free consultation to discuss your claim.
What is Botulism?
Clostridium botulinum is a gram-positive, rod-shaped, anaerobic, spore-forming, motile bacterium with no flagella and has the ability to produce botulinum toxin, which is a neurotoxin.
Botulism is a rare but serious illness. It is caused by a toxin that attacks the body’s nerves and causes difficulty breathing, muscle paralysis, and even death.
The toxin is made by Clostridium botulinum and related bacteria. There are five main kinds of botulism. All are medical emergencies.
Botulinum toxin can cause botulism, a severe flaccid paralytic disease in humans and other animals. The botulinum toxin is the most potent toxin known in scientific literature, natural or synthetic, with a lethal dose of 1.3–2.1 ng/kg in humans
Infant botulism is a rare and serious illness that occurs in babies under age 1, whose gut microbiomes are immature. It is caused when the infants consume bacteria that contain spores that produce a toxin in the gut. Symptoms include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing and breathing problems, among others.
Babies who develop those symptoms need immediate medical attention. The sole treatment for the infection is BabyBIG, an IV medication made from blood plasma of people immunized against botulism.
How is the Botulism Toxin Produced in Food?
C. botulinum spores are often found on the surfaces of fruits and vegetables and in seafood. The organism grows best under low-oxygen conditions and produces spores and toxins. The toxin is most commonly formed when food is improperly processed (canned) at home. C. botulinum cannot grow below a pH of 4.6, so acidic foods, such as most fruits, tomatoes, and pickles, can be safely processed in a water bath canner. However, foods with a higher pH (most vegetables and meats) must be processed under pressure. Therefore, a pressure cooker should be used. The pressure cooker will reach high enough temperatures to destroy the C. botulinum spores.
For example, if a low-acid food, such as green beans, is canned improperly (not canned under pressure or improperly canned using a pressure canner), C. botulinum bacteria and other bacteria present will be destroyed by the boiling of water and food, but the C. botulinum spores will not be destroyed. The canning process will remove the oxygen from the jar, creating a low-oxygen environment that is will allow the spores to grow into active bacteria. When the jars are stored at room temperature, the spores can germinate and produce the toxin. However, the toxin is sensitive to heat and can be destroyed if the food in question is boiled for 10 minutes (longer at high altitudes).
What Clinicians Should Do About Infant Botulism?
Initial diagnosis of infant botulism is based on clinical symptoms.
Consultation with the Infant Botulism Treatment and Prevention Program is available for suspected cases. If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24 hours a day, 7 days a week.
If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.
Health Advisory to Healthcare Providers
11/11/2025
Outbreak of Infant Botulism Linked to ByHeart Infant Formula
Sources
CDC Infant Botulism Outbreak Linked to Infant Formula, November 2025
FDA Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
FDA ByHeart Broadens Voluntary Recall While Investigation Continues
USDA Clostridium botulinum & Botulism
Fox Business Baby formula recalled as infant botulism outbreak grows
ABC News ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows
AP News ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows
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