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.
On November 8, 2025, 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 11, 2025, ByHeart, Inc. expanded its voluntary recall to include all batches of ByHeart Whole Nutrition Formula and Anywhere Pack products.
To date, at least 15 infants in 12 states have been hospitalized after consuming ByHeart infant formula products.
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 Meyers & Flowers Trial Attorneys, our dangerous product lawyers have decades of experience and have secured billions of dollars in compensation for our clients. Call (630) 394-5189 or visit our contact page and schedule 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.
At least 14 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
- Weak muscle tone
- Difficulty breathing
Infant botulism is a medical emergency requiring immediate hospitalization. If left untreated, it could lead to paralysis and death.
What To Do 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 Meyers & Flowers 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 Meyers & Flowers Trial Attorneys, our product liability lawyers in Chicago have the experience, skills, and resources to help secure maximum compensation for your family. Let us help you.
Call (630) 394-5189 or complete the short form on our contact page to schedule a free consultation and discuss your claim.