Nationwide Recall Issued for ByHeart Formula
Company expands voluntary recall of all Whole Nutrition Infant Formula products as federal agencies investigate a surge in infant botulism cases.
ByHeart, a New York–based infant nutrition company, has expanded its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula, including 24-ounce cans and 0.6-ounce “Anywhere Pack” single-serve packets. The action comes as the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) continue to investigate a nationwide increase in infant botulism cases.
Although no unopened ByHeart products have tested positive for Clostridium botulinum spores or toxin, company officials said they are acting “out of an abundance of caution” as federal agencies work to identify a possible source connected to 84 reported cases since August.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Mia Funt, Co-Founder and President of ByHeart. She said the company is working closely with regulators and has already begun third-party testing of every formula batch.
What the Recall Covers
The recall includes all unexpired lots of:
ByHeart Whole Nutrition Infant Formula 24 oz cans
UPC: 85004496800ByHeart Anywhere Pack™ 0.6 oz sticks
UPC: 85004496802
The products were sold online and at major retailers nationwide. According to the FDA, ByHeart represents less than 1 percent of the U.S. infant formula market, and the recall is not expected to affect national formula availability.
Why the Recall Was Expanded
Federal officials widened their recommendation after:
identifying additional illness reports involving infants who consumed ByHeart formula;
linking new suspected cases to the product;
receiving a preliminary positive sample result collected by the California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program.
The FDA emphasized that its investigation is ongoing. ByHeart said it is cooperating fully, providing access to facilities, records, and unopened product for testing.
Understanding Infant Botulism
Infant botulism is a rare but serious illness caused when Clostridium botulinum spores colonize an infant’s intestinal tract and produce neurotoxins. Early symptoms can include:
constipation
poor feeding
difficulty swallowing
drooping eyelids
weak cry
decreased muscle tone
respiratory difficulty
Symptoms can take days or weeks to appear following ingestion. Immediate medical care is recommended for any symptomatic infant.
What Parents and Caregivers Should Do
Federal officials urge consumers to stop using all ByHeart infant formula products immediately. Additional steps include:
If your child consumed the formula:
Monitor for symptoms over the next several weeks.
Seek immediate medical attention if symptoms appear.
If you still have the product:
Photograph or record the lot information.
Label the container clearly as DO NOT USE.
Store it in case state health officials request it for testing.
If no symptoms develop after 30 days, discard it.
Parents with questions may contact ByHeart at hello@byheart.com or call 1-833-429-4327. FDA consumer complaint coordinators are also available for reporting illnesses, and voluntary MedWatch forms can be submitted online or by mail.
Status of the Investigation
The outbreak investigation remains active. The FDA and CDC continue to collect samples, evaluate case histories, and review production data as they work to determine the source of the illnesses.
ByHeart says it will release testing results from independent labs and regulatory agencies as soon as they are available.
Photography: FDA | More information