The recent ByHeart formula recall has put a lot of families on alert after federal health officials connected certain ByHeart powdered formulas to an infant botulism investigation. Two lots of ByHeart Whole Nutrition Infant Formula were pulled from the market after the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention reported several cases of infant botulism across multiple states. Many parents are wondering how it might affect their children as news of the recall spreads.
At EOL.Law, we’re tracking the updates and helping families understand their options if their child used the recalled formula. We’ll go over what caused the recall, what officials are investigating, and what you can do if your child was affected.
ByHeart Baby Formula Recall Follows Infant Botulism Cases
ByHeart, a next-generation baby nutrition company, has announced a voluntary recall of certain batches of its powdered infant formula after federal officials linked the product to an infant botulism outbreak.
On November 8, the FDA and CDC confirmed that two lots of ByHeart Whole Nutrition Infant Formula were being recalled. The CDC reported 13 cases of infant botulism across 10 states connected to the formula, all of which required hospitalization. No deaths were reported as of November 9.
The recalled formula was sold online and across the country. According to the FDA, these batches represent less than 1 percent of all infant formula sold in the United States, so widespread shortages are not expected.
California’s Infant Botulism Treatment and Prevention Program, which is the only program in the world that treats infant botulism, alerted the CDC to the potential outbreak. The program continues to investigate the cases linked to the recalled formula. Testing of leftover product is in progress, and results are expected in the coming weeks.
ByHeart has stated that no toxins have been found in their products and denied that their formula caused any illness. The company explained that it decided to recall the formula to remove any potential risk from the market. This is to make sure the safety of every baby who uses ByHeart is protected.
What Is Infant Botulism?
Infant botulism is a serious condition that can affect babies, usually before their first birthday. It occurs when an infant swallows bacterial spores. Inside the baby’s intestines, these spores can grow and produce a toxin.
This toxin attacks the nervous system. It blocks the signals that tell muscles to move. This leads to severe muscle weakness, often making a baby appear limp and floppy, a symptom sometimes called “floppy baby syndrome.”
The bacteria that cause it are common in our environment; they’re found in soil and dust. This is also why doctors warn against giving honey to babies under one, as it can contain these spores.
The focus of treatment is on intensive supportive care in a hospital. The goal is to help the baby breathe and eat while the illness runs its course. The most important factor is time; with prompt medical attention, most infants make a full recovery. Because the source can be hard to pinpoint, health investigators take any potential link, such as to powdered infant formula, extremely seriously.
Symptoms of Infant Botulism
Watch for these signs in your baby:
- Constipation that lasts for several days
- Weak sucking or refusal to feed
- Trouble swallowing or excessive drooling
- Loss of head control
- Drooping eyelids
- Blank, expressionless face
- Weak or floppy arms and legs
- A faint, weak cry
- Lethargy or extreme fatigue
- Breathing difficulties
If you notice any of these symptoms, trust your instincts. Contact your pediatrician or go to the emergency room immediately. Quick medical attention gives your baby the best chance for a full recovery.
What to Know About the ByHeart Infant Formula Recall
Products:
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes every unexpired lot of formula cans as well as single-serve “anywhere pack” sticks. These products make up about 1 percent of all infant formula sold in the United States, so the ByHeart baby formula recall is not expected to cause shortages.
Where it was sold:
The formula was available online and in stores at major retailers across the country. Some products may also be found on online marketplaces, but they should not be sold or purchased.
Current status:
The ByHeart formula recall is ongoing, and federal officials are continuing to monitor the situation.
Case counts:
Total illnesses: 23
Hospitalizations: 23
Deaths: 0
Most recent illness onset: November 11, 2025
Locations:
The cases linked to the ByHeart infant formula recall have been reported in the following states: Arizona, California, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Timeline of the ByHeart Formula Recall
Current Update (November 14, 2025)
Federal health officials, including the FDA, CDC, and California’s Infant Botulism Treatment and Prevention Program, continue to investigate a multistate outbreak of infant botulism. Data suggests that some ByHeart Whole Nutrition Infant Formula might be contaminated with Clostridium botulinum, which can cause illness in infants.
As of November 14, a total of 23 infants with suspected or confirmed botulism who were exposed to ByHeart formula have been reported in 13 states. All 23 infants were hospitalized, but no deaths have been reported. Illnesses began between August 9 and November 11, 2025. The affected infants range in age from 16 to 200 days, and just under half are female.
Officials in several states have collected leftover formula for testing. Preliminary results from California suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart formula from lot 206VABP/251131P2. Additional testing is ongoing, and results are expected in the coming weeks. Detecting Clostridium botulinum in formula is challenging, and a negative result does not necessarily mean the bacteria are not present.
The FDA is continuing inspections and sample collection to determine how the formula might have been contaminated. Updates will be provided as the investigation continues.
Case Counts
- Total illnesses: 23
- Hospitalizations: 23
- Deaths: 0
- Last illness onset: November 11, 2025
- States with cases: Arizona, California, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington
- Product distribution: Online and nationwide
- November 11, 2025: The FDA recommended expanding the recall to include all ByHeart formula nationwide due to additional illnesses, identified lot codes, and preliminary positive lab results. ByHeart agreed to expand its recall to include all cans and single-serve sticks.
- November 10, 2025: Reports showed that 15 infants with suspected or confirmed botulism had consumed ByHeart formula across 12 states. Officials interviewed caregivers about foods infants were fed before becoming ill.
- November 8, 2025: The FDA and CDC, working with California health officials, confirmed 13 cases of infant botulism from 10 states. All affected infants had consumed ByHeart formula. Leftover formula was collected for testing.
Since August 1, 2025, 84 infants nationwide have received treatment for infant botulism. Of those, 36 had exposure to any powdered infant formula, and 15 had consumed ByHeart Whole Nutrition formula. This shows ByHeart formula is disproportionately represented among sick infants, even though it accounts for about 1 percent of all formula sold in the U.S. No other brands have been linked to this outbreak.
FDA Recommendations
- For Parents and Caregivers
- If you have any ByHeart infant formula at home, stop using it immediately.
- If your child has consumed the formula and shows symptoms, seek medical attention right away.
- If your child has consumed the formula but has no symptoms, continue to watch closely and contact a doctor if any signs appear.
- If you still have the formula container:
- Take a photo or note the information printed on the bottom of the package.
- Store it somewhere safe and clearly label it as DO NOT USE.
- Your state’s health department may want to collect the container for testing if your child develops symptoms. If your child remains healthy for 30 days, safely dispose of the container.
- For Retailers
Make sure recalled products are not on store shelves, including items returned by customers.
Important: Infant botulism can be life-threatening. If your baby shows signs such as poor feeding, trouble controlling their head, difficulty swallowing, or weak facial expressions, seek medical attention immediately.
- For Physicians
If you suspect an infant patient has botulism, contact the Infant Botulism Treatment and Prevention Program at 510-231-7600 for case consultation. Assistance is available 24/7.
What Should Consumers Do
If you or your baby begins showing symptoms, get in touch with your health care provider right away so they can take a closer look and let you know what to do next.
If you need to report an illness or reaction, you can:
- Call an FDA consumer complaint coordinator if you want to speak with someone directly.
- Fill out the Voluntary MedWatch form online.
- Print the paper MedWatch form and mail it to the FDA.
Parents who have questions for ByHeart can email hello@byheart.com or call 1-833-429-4327. The company says someone is available at all hours.
You can also report any concerns about the recalled formula through the FDA’s Industry and Consumer Assistance page.
Two Families Sue ByHeart Following Infant Botulism Cases
ByHeart is now facing lawsuits from the parents of two infants who became seriously ill during the ongoing infant botulism outbreak. The families, Stephen and Yurany Dexter of Flagstaff, Arizona, and Michael and Hanna Everett of Richmond, Kentucky, filed separate federal complaints after their babies were diagnosed with the rare illness. Both families believe the formula played a direct role in their children getting sick.
In the Dexters’ case, their daughter started showing troubling symptoms after being fed ByHeart formula just days after birth. According to the lawsuit, her feeding slowly declined, she grew increasingly weak, and by late August her parents struggled to wake her. She was eventually airlifted to Phoenix Children’s Hospital, treated with antitoxin, and required multiple therapies. She was discharged with a feeding tube and still needs constant supervision, the complaint says.
The Everetts reported a similar experience. Their 4-month-old daughter became lethargic and constipated shortly after consuming the formula in early November. Within days she had difficulty feeding and showed neurological symptoms. She was hospitalized on November 9, diagnosed with infant botulism, and received antitoxin treatment. The Kentucky Department of Public Health later found she had consumed one of the recalled lots. Both families are seeking compensation for medical expenses, a jury trial, and other damages.
Legal Options for Parents Affected by ByHeart Formula
Illness linked to contaminated formula can bring serious, long-lasting challenges for families. Holding the manufacturer responsible can provide support for your child’s care and recovery. With the ongoing infant milk recall FDA alert for ByHeart formula, parents need to know their legal options if their baby was affected.
If your baby became sick after using ByHeart formula, it’s important to take action right away. Families dealing with an infant botulism diagnosis or any serious illness linked to the recalled formula may be eligible to pursue compensation.
Speak with a product liability lawyer to understand your options and what steps to take next. Try to keep anything that could support your claim, including receipts, packaging, and any leftover formula.
Our team at EOL.Law handles these cases with the attention and persistence families deserve. If you want to talk through what happened or see if you have a case, you can call us or use the short form on our contact page to set up a free consultation.
Frequently Asked Questions
Has the ByHeart formula ever been recalled?
Yes, ByHeart issued a voluntary recall of its infant formula. It started with two batches in early November 2025 after the FDA opened an investigation into infant botulism cases around the country. The company later widened the recall to include all batches of its formula, including both cans and single-serve packs, as a precaution while the investigation continued. No spores or toxins have been found in unopened cans, and there is still no confirmed link between the formula and the reported cases.
Which baby formula was recalled?
The recall involves ByHeart’s Whole Nutrition Infant Formula. It began with two batches labeled 251261P2 and 251131P2, both stamped with a December 1, 2026 “Use by” date. The company then expanded the recall nationwide to include every batch of this formula in both 24-ounce cans and single-serve Anywhere Pack sticks. This step was taken voluntarily while the FDA looks into infant botulism cases reported since August 2025.
Is ByHeart a safe formula?
ByHeart’s formula is currently part of a voluntary recall while federal health agencies review infant botulism cases reported in several states. No spores or toxins have been found in any unopened cans, and testing so far has not confirmed a direct link between the formula and the illnesses. The brand does appear more frequently than others among families affected by this outbreak, which is why the investigation is continuing. Parents are being asked to stop using the recalled formula until the review is complete.
Does ByHeart formula have heavy metals?
ByHeart reports that its formula is tested for heavy metals and stays below established safety limits. The company follows strict testing standards, including California’s Prop 65, which is known for its tough rules on contaminants. Independent lab reviews have shown only trace amounts, often listed as “non-detect,” for metals like lead, cadmium, arsenic, and mercury. Based on current testing, the formula does not show unsafe levels of heavy metals.
