Infant botulism alerts spur ByHeart formula recall: what parents need to know now

A multistate investigation into infant botulism has triggered a voluntary recall of two batches of ByHeart Whole Nutrition Infant Formula. As of Nov. 11, 2025, officials report at least 15 affected infants across 12 states (no deaths). The probe is active, numbers can change, and families are being urged to check cans immediately and contact pediatricians at the first sign of symptoms.

The ByHeart formula recall at a glance

• Product: ByHeart Whole Nutrition Infant Formula (powder)

• Batches recalled: 251261P2 and 251131P2

• Best-by: December 2026 (printed on the bottom of cans)

• What to do: Do not use. Record the lot number, then return or discard the can. Clean and sanitize scoops, bottle parts, counters, and any surfaces the powder touched.

• Scope: ByHeart represents about 1% of U.S. formula sales, so overall supply should not be disrupted.

Investigators have linked illness reports across multiple states to infants who consumed the brand at some point this fall. Testing of leftover product is ongoing to determine the contamination route and whether risk is confined to the recalled lots. Updates are expected as lab work and tracebacks continue.

Botulism in babies: symptoms to watch

Infant botulism is rare but serious. In babies—especially under 12 months—bacterial spores can germinate in the gut, producing a neurotoxin that blocks muscle signals. Symptoms may appear gradually over days to weeks and often start subtly.

Call your pediatrician or seek urgent care if you notice:

• Poor feeding or weak suck; drooling, gagging, or difficulty swallowing

• Constipation (a common early sign)

• Floppy arms/legs, weak cry, head lag, lethargy

• Trouble breathing or shallow respirations

The standard treatment is botulism immune globulin (BabyBIG®), an antitoxin that neutralizes circulating toxin and shortens illness if given promptly. Many infants require hospital care for feeding support and respiratory monitoring; with timely treatment, outcomes are typically good.

Safety checklist for families who purchased ByHeart

1. Check every can at home, daycare, and with caregivers; photograph the bottom for lot and best-by.

2. If you used a recalled lot, stop immediately and call your pediatrician, even if your child feels fine. Some cases take time to declare.

3. Sanitize: Wash hands; run bottles, nipples, rings, and caps through hot, soapy water (or dishwasher high-heat setting). Wipe and disinfect counters, scoops, and storage bins.

4. Save documentation: Note purchase dates, retailer, and lot numbers in case you’re contacted by health authorities or pursue a refund replacement.

5. Never feed honey to infants <12 months; while unrelated to formula manufacturing, honey is a well-known spore source.

Why this recall matters—and what’s being investigated

Powdered infant formula is a low-moisture food, but spores can persist in dry environments. The questions investigators are working to answer include where and when contamination occurred (ingredient sourcing, processing, packaging, or post-purchase handling) and whether any risk extends beyond the two lots. Early epidemiology centers on the recalled batches; confirmation depends on culture, toxin, and whole-genome testing of product and environmental samples.

If your can isn’t part of the recall

• You can continue feeding non-recalled formula. If you prefer to switch brands temporarily, do so under your pediatrician’s guidance.

• Follow strict formula hygiene: close lids tightly, use clean/dry scoops, avoid humid storage, prepare with safe water, and discard mixed formula left at room temperature for more than two hours (one hour if warm).

Quick answers to trending questions

Is every ByHeart product unsafe?
No. The recall targets two specific batches. The broader brand remains under review, but current action is limited to the lot numbers above.

My baby finished a recalled can and seems fine—now what?
Call your pediatrician for guidance and symptom monitoring. Keep a photo of the can’s bottom and note dates of use.

Will stores accept returns without a receipt?
Policies vary. Many locations honor safety recalls with proof of product and lot photo.

Could this affect other formulas?
The investigation focuses on ByHeart at this time. If scope widens, officials will publish new lot numbers and brands; until then, no change is recommended for other formulas.

If you have ByHeart Whole Nutrition Infant Formula, check the bottom of the can now. If it reads 251261P2 or 251131P2 with best-by December 2026, stop using it, sanitize gear, and contact your pediatrician—especially if your infant shows any feeding, muscle, or breathing changes. This is a developing investigation; expect updates as lab results and tracebacks come in.