November 12, 2025: A ByHeart lawsuit was filed in response to the infant formula recall. The infant formula lawsuit, filed by a Kentucky couple, alleges negligence against ByHeart for failing to warn about the possible contamination of its infant formula “by dangerous pathogens despite a history of contamination of its products and/or at its manufacturing facility.” The lawsuit seeks punitive damages.
November 11, 2025: The ByHeart botulism outbreak remains under active investigation by the FDA, CDC, and state health departments. After the FDA identified two additional cases, ByHeart expanded the recall to include all formula products nationwide—approximately 200,000 cans sold monthly.
Key developments to watch:
- Testing Results – ByHeart has engaged third-party laboratories to test unopened cans from recalled batches. The company insists testing an unopened product is necessary to “provide reliable evidence” and establish whether contamination exists in sealed formula. However, health officials acknowledge that testing for Clostridium botulinumin powdered formula is “difficult, and a negative test result does not rule out the presence of the bacteria.”
- Additional Botulism Cases – Because botulism symptoms can take up to 30 days to appear, more cases could emerge. Any infant who consumed ByHeart formula through early November 2025 remains at potential risk.
- FDA Investigation – The agency is investigating to “determine the point of contamination” in ByHeart's manufacturing process. Given the company's documented history of contamination control failures, this investigation will likely scrutinize whether ByHeart implemented corrective actions after the 2023 FDA warning letter.
November 9, 2025: California health officials announced preliminary testing found Clostridium botulinum in an opened can of ByHeart formula from a sick infant's home.
November 8, 2025: ByHeart recalls were issued for two specific lots of formula (251261P2 and 251131P2).
November 7, 2025: The FDA notified ByHeart that 13 of 83 nationwide botulism cases since August involved infants who consumed their formula.
ByHeart Formula Recall – Infant Botulism Outbreak
The infant botulism outbreak began in August 2025. By early November, California's Infant Botulism Treatment and Prevention Program—which monitors every case of infant botulism nationwide—noticed something unusual: multiple babies with confirmed botulism had consumed ByHeart formula.
According to the U.S. Food and Drug Administration, at least 15 infants have been hospitalized with suspected or confirmed botulism across Arizona, California, Illinois, Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The babies ranged in age from 16 days to just over 5 months. All received treatment with BabyBIG, a specialized antitoxin that can cost roughly $69,300 per vial. None have died, though botulism causes progressive paralysis that can stop breathing if untreated.
Where Is ByHeart Formula Sold?
ByHeart sells formula online and at major retailers nationwide, including Target, Walmart, Whole Foods, and Albertsons. The company launched in Target stores in August 2023 after receiving FDA registration in March 2022.
Despite marketing itself as a premium, safety-focused brand, among the 84 babies treated for botulism since August 2025, 43% had been exposed to powdered formula—and more than 40% of those consumed ByHeart formula.
According to the FDA, ByHeart infant formula was “disproportionately represented” among babies who were sickened with botulism, especially considering the company’s sales account for only 1% of all infant formula sales in the U.S.
ByHeart's Troubling Safety Record
This is not ByHeart's first baby formula recall. It is also not the first time regulators have raised serious concerns about contamination at the company’s facilities.
December 2022 – ByHeart Cronobacter Contamination Reported
In December 2022, less than a year after launching, ByHeart recalled five batches of formula after Cronobacter sakazakii was detected at a third-party packaging facility. Cronobacter can cause severe and potentially fatal infections in infants, including sepsis and meningitis. While no distributed product tested positive, the company destroyed all formula produced during that production run.
August 2023 – ByHeart Receives FDA Warning Letter for Infant Formula Manufacturing Violations
Eight months later, the FDA sent ByHeart a formal warning letter documenting “significant violations” of infant formula manufacturing requirements.
FDA investigators found that ByHeart failed to establish process controls to prevent microorganism contamination in their infant formula. The warning letter detailed multiple alarming findings:
- Root Cause Failures: When the finished product tested positive for Cronobacter, ByHeart blamed laboratory error—even though the third-party lab concluded “laboratory error was not found or supported.” The company released other formula from the same contaminated production campaign without conducting an adequate investigation.
- Manufacturing Violations: According to production records, maintenance work on equipment created product contamination risk, but “was not treated, verified, and recorded as an intervention into a product contact zone.” One batch of infant formula base tested positive for Cronobacter after improper equipment repairs exposed product surfaces to environmental contamination.
- Environmental Contamination: Multiple environmental swabs tested positive for Cronobacter throughout the facility. When water leaked from the building into manufacturing areas, ByHeart's root cause analysis “never considered or evaluated whether the leak may have contributed to the contamination.”
- Releasing Contaminated Product: Despite finding contamination, ByHeart still allowed adulterated powdered infant formula to be released into commerce between October 17, 2022 and November 14, 2022, and failed to notify the FDA.
“We may be seeing history repeat itself with ByHeart,” says attorney Monique Alarcon. “They previously knew about contamination risks, and they had multiple opportunities to investigate and prevent distribution of potentially unsafe formula. Instead, according to the FDA, they released product without adequate safeguards.”
Understanding Infant Botulism
Infant botulism occurs when a baby swallows spores of Clostridium botulinum, which then grow in the intestines and produce a neurotoxin—one of the most poisonous substances known. Adults can typically fight off these spores, but babies under one year have immature digestive systems that can't destroy the bacteria.
How Does Botulism Affect Babies?
Infant botulism attacks the body's nerves, causing widespread muscle weakness and paralysis. Without prompt medical treatment, the paralysis can spread to the muscles used for breathing, which can be fatal.
Key Warning Signs to Watch For
Symptoms typically progress in a descending pattern (from head to toe) and can vary in severity. If an infant displays any of these signs, seek emergency medical care immediately.
| Symptom Category |
Specific Signs in Infants |
| Muscle Weakness |
Loss of head control ("floppy" baby), decreased movement, lack of facial expressions, decreased muscle tone. |
| Feeding/Swallowing |
Poor feeding, weak sucking, difficulty swallowing, excessive drooling. |
| Digestion |
Constipation (often the first and most common symptom, though easily overlooked). |
| Nervous System |
Drooping eyelids (ptosis), sluggish or slow-to-react pupils, weak or altered cry. |
| Breathing |
Breathing difficulties, respiratory distress, or respiratory arrest. |
| Overall State |
Extreme tiredness (lethargy). |
Onset and Monitoring
Symptoms of infant botulism can be slow to appear, with a variable incubation period because the exact date of spore ingestion is usually uncertain. The onset of symptoms can range from several days to weeks (up to 30 days or more) after exposure.
Parents and caregivers who have used potentially contaminated products (including ByHeart baby formula) must remain vigilant and monitor their infant closely for an extended period. The delayed onset means that new cases may still emerge from exposure that occurred weeks earlier.
Do not wait for laboratory confirmation of the illness; immediate medical evaluation is crucial if symptoms are suspected.
What is the Treatment for Infant Botulism?
All 15 infants in the current outbreak received BabyBIG (Botulism Immune Globulin Intravenous). BabyBIG works by neutralizing the botulinum toxin circulating in the baby's bloodstream. The treatment can dramatically reduce hospital stays and improve health outcomes.
Even with treatment, some infants may face long-term complications, including developmental delays, nerve damage, motor skill disabilities, and ongoing health problems, which is why our law firm is investigating potential lawsuits against ByHeart. If negligence is a factor in the latest ByHeart baby formula recall that left infants with serious health issues, the company may be held liable for damages.
Why The Latest Baby Formula Recall Could Lead to Major Litigation
Product contamination cases follow well-established legal principles. When a manufacturer sells a defective product that harms consumers, they can be held liable under multiple legal theories.
Strict Liability: In many states, companies that sell contaminated food products face strict liability—meaning families don't need to prove negligence, only that the product was contaminated and caused harm.
Negligence: ByHeart's documented safety violations may strengthen negligence claims. The August 2023 FDA warning letter details the company's failure to prevent microorganism contamination, inadequate investigation of positive contamination findings, and release of potentially adulterated product. These facts could potentially support claims that ByHeart knew or should have known their manufacturing processes created contamination risks.
Wisner Baum's Experience With Baby Food Litigation
We understand what families face when trusted infant products turn out to be dangerous.
Wisner Baum is currently leading consolidated litigation against major baby food manufacturers for selling products contaminated with toxic heavy metals. We represent thousands of families nationwide whose children developed autism and ADHD after consuming tainted baby food.
Our managing partner, R. Brent Wisner, serves as co-lead trial counsel in the toxic baby food multidistrict litigation (MDL). We are no strangers to the fight for corporate accountability because we have seen time and time again that voluntary standards and delayed regulations haven't worked. In the baby food litigation, we have obtained discovery documents showing that some manufacturers knew about toxic contamination but continued selling products marketed as safe. When companies choose profits over infant safety, litigation becomes necessary to force industry-wide change.
Free Case Evaluation: Do You Qualify for a ByHeart Lawsuit?
You may have a claim if your baby:
- Consumed ByHeart Whole Nutrition Infant Formula (cans or Anywhere Pack sticks) and was diagnosed with infant botulism or experienced symptoms including constipation, weak cry, poor feeding, loss of head control, breathing difficulties, or hospitalization.
Time limits apply to product liability cases. Each state has a statute of limitations that restricts how long you have to file a lawsuit. Waiting too long could prevent you from recovering compensation, even if your baby was seriously harmed.
Wisner Baum offers free, confidential case evaluations for families affected by the ByHeart recall. We never charge upfront fees, and we only get paid if we recover compensation for you.
Call (310) 207-3233 or complete our online form to speak with an experienced attorney.
Our team will review your baby's medical records, assess the strength of your claim, explain your legal options, and answer all of your questions. You have nothing to lose by calling and are under no obligation to retain us in this emerging litigation.
