A U.S. Food and Drug Administration investigation is ongoing after 13 babies were hospitalized with infant botulism across 10 states. According to a report issued by the FDA on November 8, 2025, the FDA and CDC’s “ongoing investigation found an increase in the number of botulism infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025.” Parents and caregivers will want to check their infant formula at home—and at caregiving locations—to ensure it’s not part of the latest recall of ByHeart Whole Nutrition infant formula.
Botulism is an intestinal toxin that can make babies very sick. According to the report,” most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest.” Botulism can be fatal, but luckily, no deaths have yet been reported; however, the investigation is still ongoing. Here’s what to know about the ByHeart Whole Nutrition infant formula recall:
Which formula is affected by the latest recall?
Two lots of ByHeart Whole Nutrition infant formula are part of the recall:
- Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
According to the report, the lot code and “Use by” date are located on the bottom of the infant formula can (pictured below).
At this point, no other ByHeart nutrition products or other formula brands are affected by this recall. And, according to the report, “ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1 percent of all infant formula sold in the United States, and this outbreak does not create shortage concerns of infant formula for parents and caregivers.”
Where was the recalled ByHeart formula sold?
The multistate outbreak of 13 infant botulism illnesses includes 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, and Texas (2).
ByHeart Infant formula is sold at major retailers nationwide and online.
What is infant botulism?
According to the CDC’s website, infant botulism is an intestinal toxemia that can take weeks to present after ingestion. “The disease results after spores of the bacterium Clostridium botulinum or related species are swallowed. These spores temporarily colonize an infant’s large intestine and produce botulinum neurotoxin.”
Babies will present with some or all of the following signs and symptoms:
- Constipation
- Poor feeding
- Ptosis (drooping eyelid)
- Sluggish pupils
- Flattened facial expression
- Diminished suck and gag reflexes
- Weak and altered cry
- Respiratory difficulty and possibly respiratory arrest
Botulism can be fatal, so parents and caregivers should seek medical help right away if they notice any of the above symptoms.
What should you do if you have the recalled ByHeart Whole Nutrition infant formula?
If your ByHeart Whole Nutrition infant formula is part of the recall, do not use this product and discard it. If your child is experiencing any of the symptoms above after consuming ByHeart Whole Nutrition infant formula, contact your child’s pediatrician immediately.
And you still have the formula in your home, please record the information on the bottom of the package before throwing it away to help with the ongoing investigation.
Kathy Sisson, Senior Editor
Kathy Sisson has been a key contributor in the editorial parenting space for eight years, not only as a full-time editor at The Everymom but previously as a freelance writer for top parenting sites, including Scary Mommy, Motherly, Parent Co., and more. As an editor at The Everymom, she has produced hundreds of articles on a range of parenting topics, reviewed dozens of family-focused products, interviewed leading experts in the children and parenting world, and created viral parenting social media content. A mom of two, she is committed to sharing the honest, helpful, and often humorous stories of motherhood.
The post ByHeart Recalls Infant Formula Over Safety Concerns—Check If Yours Is Affected appeared first on The Everymom.
Source link: https://theeverymom.com/byheart-infant-formula-recall/ by Kathy Sisson at theeverymom.com