The Carlson Law Firm is representing families nationwide against ByHeart manufacturers for selling a product harmful to infants. Learn if your family qualifies for compensation for a claim with a free consultation from our ByHeart Botulism Lawsuit Lawyers. We’re available to help clients nationwide.
Federal health officials have linked ByHeart infant formula to a multistate outbreak of infant botulism, prompting a nationwide recall and hospitalizations across the U.S. In November 2025, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) identified a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition powdered infant formula. As a result, the following occurred:
Learn more by scheduling a free consultation with our qualified ByHeart Botulism Lawsuit lawyers.
Your baby consumed ByHeart Whole Nutrition formula (including single-serve packs) that was recalled.
A healthcare provider confirmed a diagnosis of infant botulism (or related illness), suffered complications or was hospitalized.
The illness occurred, particularly relating to formula used between December 2023 and the November 2025 recall.
ByHeart is an American Infant formula company founded in 2016, and its products are marketed as whole-nutrition formula for infants. The company was founded to create an infant formula modeled more closely after breast milk. It is one of the few companies with end-to-end manufacturing capabilities.
The company launched its first infant formula in March 2022, during a time the United States was facing a formula shortage. It became the first new FDA-registered formula manufacturer in more than 15 years.
The Carlson Law Firm has handled complex cases involving baby formula, including necrotizing enterocolitis (NEC) lawsuits against the manufacturers of Enfamil and Similac.
In November 2025, Health officials linked the outbreak to contamination of the formula with Clostridium botulinum, a bacterium that produces a potent neurotoxin. Babies under 12 months of age are especially susceptible to this toxin because their digestive systems cannot prevent spores from germinating and producing toxin once ingested.
Recent testing by the FDA and CDC has also indicated that organic whole milk powder used in ByHeart formula production tested positive for C. botulinum spores, suggesting a possible source of contamination.
If your baby was hospitalized with botulism after being fed ByHeart Infant Formula, speak with an attorney to learn about your options.
In 2025, ByHeart issued a nationwide voluntary recall of all batches of its Whole Nutrition Infant Formula, including both cans and Anywhere Pack™ products. The recall followed a federal investigation linking the formula to a multistate outbreak of infant botulism, a rare but potentially life-threatening illness.
The recall was announced after testing identified the possible presence of Clostridium botulinum, a bacterium that can produce a powerful neurotoxin when ingested by infants. Because babies under one year old lack the digestive defenses needed to prevent the bacteria from colonizing, even low-level exposure can pose serious health risks.
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The first step is to schedule a consultation with a specialized product liability attorney. During this meeting, you'll discuss the details of your case, including any harm caused by the baby formula, evidence you have (such as medical records or product packaging), and potential legal strategies. Our team will evaluate the viability of your case and explain your legal options, including the likelihood of success and possible compensation.
If our team determines that you have a strong case, the next step is an in-depth investigation. This involves gathering all necessary evidence, consulting with medical experts, and identifying all liable parties. Your attorney will then file the lawsuit in the appropriate court, outlining the legal basis for your claim and the damages you seek. The defendants (e.g., the baby formula manufacturer) will be served with the complaint and given a chance to respond.
Because they are incredibly complex claims, mass torts claims can take several years to resolve. Once the lawsuit is filed, the litigation process begins. This includes discovery (exchange of evidence between parties), depositions (interviews under oath), and possibly pre-trial motions. Throughout this period, your attorney will negotiate with the defendants' legal team to reach a settlement. Many cases are resolved through settlement negotiations to avoid the uncertainty and expense of a trial. If a fair settlement cannot be reached, the case will proceed to trial, where a judge or jury will determine the outcome.
If you have more questions about the lawsuit process, give us a call today at 800-359-5690. Consultations are free and confidential.
The recall was prompted by an outbreak investigation conducted by the CDC in coordination with the FDA. The investigation identified a link between consumption of ByHeart formula and cases of suspected or confirmed infant botulism across multiple U.S. states.
According to federal health authorities, the recall applies to:
Parents and caregivers were instructed to stop using the recalled formula immediately, regardless of whether symptoms were present.
Federal authorities continue to investigate how Clostridium botulinum may have entered the formula supply, including potential ingredient sourcing, manufacturing, or handling issues. Additional findings may emerge as the investigation progresses.
For families whose infants became ill after consuming ByHeart formula, the recall represents a critical acknowledgment that the product may have posed a serious health risk.
According to reports from the CDC and FDA, at least 51 infants in 19 states have been hospitalized with suspected or confirmed infant botulism after consuming ByHeart Whole Nutrition infant formula. These cases span multiple regions of the country, underscoring the nationwide scope of the outbreak and the seriousness of the contamination concerns.
While no deaths have been reported, infant botulism is considered a medical emergency. Most affected infants required extended hospital stays, often in intensive care units, due to the rapid and potentially life-threatening progression of the illness. Some infants needed breathing support, tube feeding, or prolonged monitoring while their nervous systems recovered.
Families may be eligible to pursue a ByHeart infant formula lawsuit if their child was harmed after consuming ByHeart Whole Nutrition Infant Formula. Eligibility depends on the specific facts of each case, but families may want to explore their legal options if the following apply:
Even if a formal diagnosis was not immediately made, families whose infants experienced sudden weakness, feeding difficulties, constipation, or respiratory distress after consuming ByHeart formula may still wish to seek legal guidance.
Each case is evaluated individually. Speaking with a ByHeart Botulism Lawsuit attorney can help families understand whether they qualify to pursue a claim related to the ByHeart botulism outbreak and recall.
Bacterial contamination in infant formula is a serious public health concern, particularly because infants under one year old are highly vulnerable to foodborne pathogens. For this reason, the FDA requires infant formula manufacturers to follow strict safety, sanitation, and testing standards designed to prevent contamination during production, packaging, and distribution.
In December 2022, ByHeart issued a voluntary recall of five batches of its infant formula after detecting possible Cronobacter sakazakii contamination, a bacterium that can cause severe, sometimes fatal infections in infants. While no illnesses were reported in connection with that recall, Cronobacter contamination has historically been associated with serious outcomes in newborns and young infants.
Following the 2022 recall, the FDA conducted an inspection of ByHeart’s manufacturing facility in Reading, Pennsylvania, between December 2022 and February 2023. The inspection was part of broader federal oversight of infant formula manufacturing in the United States.
After the inspection, the FDA issued a warning letter citing violations of infant formula manufacturing regulations, including quality control and production standards. ByHeart submitted multiple corrective action plans in response.
According to FDA statements, the agency later indicated that ByHeart had addressed the observations identified during the inspection and stated that it did not advise parents or caregivers to discard or avoid purchasing any specific infant formula at that time. Public records indicate that ByHeart currently has no open questions from the FDA regarding that warning letter.
After the inspection period, ByHeart announced that it had acquired two additional manufacturing facilities, stating that the expansion was intended to strengthen production capacity and meet or exceed federal quality and safety requirements for infant formula.
In 2025, a separate bacterial contamination issue emerged when federal health authorities linked an outbreak of infant botulism to ByHeart Whole Nutrition infant formula. This outbreak involves Clostridium botulinum, a bacterium distinct from Cronobacter, and has resulted in hospitalizations of infants across multiple U.S. states.
Federal agencies continue to investigate how C. botulinum spores may have entered the formula supply. While the bacteria involved in the 2022 recall and the 2025 botulism outbreak are different, both incidents underscore the critical importance of contamination prevention, ingredient testing and manufacturing controls in infant formula production.
Federal health officials advised families who purchased ByHeart formula to:
The CDC and FDA emphasized that even healthy-appearing infants should no longer be fed the recalled formula due to the risk of delayed symptom onset.
Infant botulism poisoning symptoms may appear within weeks after consumption and can include the following:
Symptoms can progress quickly and may require urgent medical care. If your infant was hospitalized after being given ByHeart Infant Formula, schedule a free consultation at 800-359-5690 with our ByHeart botulism lawsuit attorneys.
Parents and caregivers were advised to stop using the formula immediately, keep the product and packaging intact, label it “DO NOT USE,” take photographs of the packaging and lot information, and monitor infants closely for symptoms. Medical care should be sought immediately if symptoms develop.
The ByHeart infant formula recall was issued after federal health officials linked ByHeart Whole Nutrition Infant Formula to a multistate outbreak of infant botulism. The recall applies to all batches and lot numbers, including cans and Anywhere Pack™ products. Parents and caregivers were advised to stop using the formula immediately due to the potential presence of Clostridium botulinum.
Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores grow in an infant’s digestive system and produce a powerful neurotoxin. Babies under one year old are particularly vulnerable because their digestive systems are not fully developed and cannot prevent the bacteria from producing toxin.
Symptoms may develop days or even weeks after exposure and can include constipation, poor feeding or weak sucking, loss of muscle tone, drooping eyelids, reduced facial expression, difficulty breathing, weak crying, or loss of head control. Infant botulism is a medical emergency and requires immediate medical attention.
According to the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration, at least 51 infants in 19 U.S. states have been hospitalized with suspected or confirmed infant botulism linked to ByHeart formula. No deaths have been reported, but many infants required hospitalization and intensive care.
According to the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration, at least 51 infants in 19 U.S. states have been hospitalized with suspected or confirmed infant botulism linked to ByHeart formula. No deaths have been reported, but many infants required hospitalization and intensive care.
Parents were advised to stop using the recalled formula even if no symptoms developed, as infant botulism can have a delayed onset. Families with concerns may wish to consult a healthcare provider and retain any remaining product.
Parents seeking information about their rights may choose to speak with an attorney experienced in infant formula litigation to better understand whether they qualify for a claim related to the ByHeart botulism recall.
The Carlson Law Firm has been helping clients and families since 1976. If your baby was hospitalized from infant botulism poisoning after being given ByHeart Infant Formula, we can help. Our attorneys have extensive experience in handling similar claims involving infant formula negligence.
Schedule your free consultation with our ByHeart Infant Formula Lawsuit attorneys today by calling 800-359-5690.
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