ByHeart Formula Recall: What Parents Should Know
Updated: Oct 6
Reviewed and updated October 6, 2026.
Federal investigators linked ByHeart Whole Nutrition Infant Formula to 48 cases of infant botulism. Every affected infant was hospitalized. No deaths were reported.
The outbreak itself is over, but the public-health work is not. The FDA’s current investigation page says its outbreak investigation has ended while an ingredient-focused root-cause investigation continues. Parents should also understand a simpler point: all ByHeart infant-formula products remain recalled, regardless of lot number or package format.
The final federal count
FDA’s final case table reports:
48 illnesses in 17 states;
28 confirmed and 20 probable cases;
48 hospitalizations;
no deaths; and
a last reported illness onset of November 29, 2025.
Alabama was not among the states with a reported case. That does not change the recall instructions. ByHeart formula was sold online and nationwide, including cans and single-serve products that could remain in a home after the outbreak ended.
What products were recalled
The recall covers every lot and format of ByHeart Whole Nutrition Infant Formula, including:
formula cans; and
single-serve “Anywhere Pack” sticks.
The recall began with two batches on November 8, 2025 and expanded to the entire product line on November 11. A parent does not need to identify one of the original batch numbers before acting. FDA’s instruction is not to use any ByHeart infant formula.
What investigators established—and what remains open
The distinction matters. Epidemiologic and laboratory evidence established that ByHeart formula was the source of the outbreak. Federal and state testing found Clostridium botulinum in finished formula, and whole-genome sequencing connected organisms found in formula, an ingredient, and at least one clinical isolate.
FDA later identified the organism in a powdered-milk ingredient. Its June 3 update says inspections of ByHeart facilities did not identify another factor inside those facilities that explained the outbreak. FDA therefore shifted its continuing work toward ingredients, supplier controls, surveillance, prevention, and compliance.
That is strong evidence of the product-outbreak connection. It is not a final public explanation of how contamination entered the supply chain. FDA still describes the root-cause work as ongoing.
Symptoms require prompt medical attention
Infant botulism affects the nervous system. FDA identifies early symptoms that can include:
constipation;
poor feeding;
loss of head control;
difficulty swallowing;
drooping eyelids or decreased facial expression;
a weak cry; and
reduced muscle tone.
The condition can progress to difficulty breathing or respiratory arrest. If an infant consumed ByHeart formula and has symptoms, FDA instructs caregivers to seek medical attention immediately. If the infant consumed the product but has no symptoms, FDA advises continued monitoring and medical attention if symptoms develop.
This article cannot diagnose an illness. A parent with an immediate medical concern should contact a health professional or emergency service, not wait for a legal review.
What to do with recalled formula
Follow FDA’s current recall instructions:
Stop using the formula.
Keep it away from children and anyone who might prepare it by mistake.
Follow the manufacturer’s or retailer’s current return or disposal instructions.
Wash bottles, utensils, counters, and other items or surfaces that may have touched the formula with hot soapy water or in a dishwasher where appropriate.
Record the product name, package type, lot or manufacturing code, purchase location, and purchase date before discarding anything.
If an infant became ill, preserve photographs of the container and code, purchase records, medical records, and any communications with the retailer or manufacturer. Do not delay medical care to collect evidence.
What the recall proves in an individual case
A recall is important evidence, but it does not decide every claim. A particular case may still turn on whether the infant consumed the product, when symptoms began, the medical diagnosis, other possible exposures, and the damages that followed.
The legal questions can also differ from the public-health questions. FDA can identify a product as the source of an outbreak without deciding who may be legally responsible to a particular family. A civil claim ordinarily requires evidence connecting the product and the injury to the people or companies against whom relief is sought.
For a general explanation of Alabama defective-product claims, read Product Liability and the AEMLD in Alabama.
Frequently asked questions
Is the ByHeart outbreak still active?
No. CDC declared the outbreak over on February 26, 2026, and FDA says the outbreak investigation has ended. FDA’s separate root-cause and prevention work continues.
Were 51 infants affected?
Federal agencies initially reviewed 51 infants. Three were later diagnosed with other illnesses and removed from the count. The final federal total is 48: 28 confirmed cases and 20 probable cases.
Did any infant die?
No death was reported in FDA’s final case count. Every one of the 48 affected infants was hospitalized.
Is one lot safe to use?
FDA does not make that distinction. All ByHeart Whole Nutrition Infant Formula products are recalled, including all cans and single-serve sticks.
Was Alabama included?
Alabama was not listed among the 17 states with a reported case. The product was sold online and nationwide, so Alabama families should still check for recalled formula.
Primary sources
Discuss an Alabama product-injury matter
If a child was diagnosed with infant botulism after consuming recalled formula, the Law Offices of Elliott Owen Lipinsky can review the facts and explain a practical next step. Call (334) 230-7986 or request a free case review.
This article provides general information, not legal or medical advice. Recall information can change. Use the linked FDA sources for current instructions. Contacting the firm does not create an attorney-client relationship. Representation begins only after the firm accepts a matter in writing. Do not send medical records, confidential information, or time-critical material through a website form.
