Health authorities are currently investigating a cluster of infant botulism cases linked to a specific baby formula, and the formula maker has voluntarily recalled the affected batches. Infant botulism is very rare but can be serious, so it’s natural for parents to be alarmed. Rest assured, officials say there is no proof that any formula was intentionally contaminated. The recall is a precautionary measure based on an epidemiologic link. In this article we explain what infant botulism is, review the recent outbreak and recall of ByHeart Whole Nutrition Infant Formula, describe typical symptoms, and offer practical advice for concerned parents.
What Is Infant Botulism?
Infant botulism is a rare illness caused when Clostridium botulinum spores are ingested and grow in a baby’s immature gut. These bacteria produce a potent toxin that affects nerves and causes muscle weakness or paralysis. Each year in the U.S. fewer than about 200 cases are reported, almost all in babies under 6–12 months old. (Older children and adults generally don’t get it because their gut flora can destroy the spores.) The most well-known cause of infant botulism is honey or honey-containing foods – even a tiny bit of honey given to a young baby can contain dormant spores. For this reason, pediatricians strongly advise never giving honey to a child under 1 year. Aside from honey, spores can come from common sources like household dust or soil (for example, a baby crawling on a bare floor). This makes the disease so rare that it only occurs when just the right conditions align.
When spores do get into an infant’s gut, they germinate and release botulinum toxin. This toxin attacks the nervous system, leading to symptoms such as trouble swallowing, weak muscles, and eventually breathing problems. Without treatment, botulism can be life-threatening, but fortunately there is an effective antitoxin (BabyBIG®) that neutralizes the toxin. When caught in time, nearly all infants recover fully. In the recent outbreak, all hospitalized babies received antitoxin and no deaths have been reported.
Symptoms of Infant Botulism
Symptoms of infant botulism typically start with mild signs that can be easy to miss. Early on, parents might notice constipation and poor feeding. As the toxin spreads, the baby often develops more obvious signs of weakness. Common symptoms include:
- Constipation (no bowel movement for days)
- Poor feeding or weak suck (baby doesn’t feed as strongly or frequently)
- Drooping eyelids (ptosis) or reduced facial expression (baby looks “floppy”)
- Reduced muscle tone (weak limbs or head control; “floppy baby syndrome”)
- Weak or altered cry (quieter or croaky than normal)
- Difficulty swallowing or choking during feeding
- Sluggish or small pupils, difficulty focusing
- Respiratory changes (slowed breathing or difficulty breathing as the illness worsens)
These symptoms can appear gradually over days or even a week or two. Importantly, the CDC warns that symptoms may take weeks to develop after exposure, so parents should remain vigilant. Any baby showing a combination of feeding problems, muscle weakness, or breathing trouble should be evaluated by a doctor immediately. Time is of the essence because early treatment improves recovery. With prompt care, most infants fully recover muscle strength over a few weeks.
Recent Outbreak and Formula Recall
In November 2025, U.S. health authorities confirmed an outbreak of infant botulism linked to a particular baby formula. As of Nov. 8, 2025, CDC reported 13 infants from 10 states (Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington) had been diagnosed with botulism. All 13 babies were hospitalized and treated with the botulism antitoxin (BabyBIG®), and thankfully no deaths occurred. CDC notes the infants ranged from about 16 to 157 days old (roughly 2 weeks to 5 months).
Most importantly, investigators found that every one of the 13 affected infants had been fed the same brand of formula – ByHeart Whole Nutrition Infant Formula. In fact, parents in each case reported giving their baby powdered ByHeart formula in the month before illness. (For context, ByHeart Whole Nutrition makes up only an estimated 1% or less of all infant formula sold in the U.S., so this was a very small niche brand.) All cases involved the same two production lots of ByHeart formula. No other brands or products have been linked to this outbreak.
ByHeart, Inc. (the formula maker) announced on November 8, 2025 that it would voluntarily recall the two affected lots of Whole Nutrition Infant Formula out of an “abundance of caution”. The specific batches recalled are:
- Lot 206VABP/251261P2 (use-by date 01 Dec 2026)
- Lot 206VABP/251131P2 (use-by date 01 Dec 2026)
Each can has the batch code and expiration date printed on the bottom. These were sold online and at major retailers (including Amazon, Target, Walmart, Whole Foods, Kroger, etc.). No other ByHeart batches are affected, and no other manufacturer has issued any botulism-related recalls.
The FDA and CDC continue to investigate how the contamination happened. So far, laboratory testing of leftover formula and samples is underway. As CDC reports, results are expected in the coming weeks. In parallel, public health officials have urged ByHeart to recall the lots because of the strong epidemiological link to illness. CDC notes the FDA “recommended the firm conduct a voluntary recall due to the number of cases, severity of illness, and the strong epidemiological signal,” and ByHeart agreed to recall the two lots consumed by sick infants.
It’s important to stress that no direct contamination of the product has been confirmed. In their announcement, ByHeart emphasized that neither the company’s own testing nor FDA/CDC testing has found botulism spores or toxin in any formula. In fact, health officials point out that no baby formula has ever been known to cause botulism in the past. The recall is a precaution given the investigation. Officials note that infant botulism normally comes from environmental sources (like dust or honey), not dairy products, and this cluster is unprecedented.
In summary: 13 infants got sick, all had consumed ByHeart formula from two lots, and ByHeart voluntarily recalled those lots. The investigation is ongoing, but parents should act on the recall notice now.
Why Was the Formula Recalled?
You might wonder: if no formula contamination is proven, why recall at all? The answer is caution. Public health agencies take even a small chance of infant illness seriously. In this case, the link was strong enough that FDA and CDC urged ByHeart to pull the suspect batches immediately. ByHeart’s own statement explained they were acting “out of an abundance of caution” to “remove any potential risk from the market” even though no pathogen has been found in the product.
In practical terms, the recall ensures that those two lots of formula are no longer used by any families while testing continues. It also signals to parents and doctors to watch for symptoms if infants consumed the product. Without the recall, it would be hard to contain risk or gather data. By taking this step, ByHeart and the FDA aim to keep infants safe.
It’s worth noting that the U.S. formula market is robust. FDA has pointed out that ByHeart Whole Nutrition represents less than 1% of U.S. formula sales, so removing these cans should not cause any shortage of baby formula. Parents who use other brands or other lots of ByHeart formula (outside the recalled codes) have no known risk.
Symptoms to Watch For and When to Seek Care
If your baby has been fed the recalled ByHeart formula, stay alert for any unusual symptoms (see above). Because botulism can progress, immediate medical attention is recommended if any warning signs appear. According to CDC and FDA guidance, watch for:
- New difficulty feeding or losing interest in breast/bottle, or a weak/noisy suck
- Constipation or not pooping for several days
- Drooping eyelids or decreased facial expression (baby looks sleepy, weak eyelid muscle)
- Weak cry (softer or breathy compared to normal)
- Poor head control or floppy limbs (baby seems unusually limp when picked up)
- Trouble swallowing or choking on feedings
- Labored breathing or breathing pauses (medical emergency)
If you notice any combination of the above symptoms after using the formula, call your pediatrician immediately or go to the emergency room. Explain that the baby consumed the recalled formula – that will help doctors consider botulism and test for it quickly. Early treatment with botulism antitoxin is critical for the best recovery, and no infant in this cluster died once treatment began.
What Should Parents Do Now?
If you have purchased ByHeart Whole Nutrition Infant Formula, check the bottom of each can for the lot code. Only the two specific lots listed above (206VABP/251261P2 and 206VABP/251131P2, both expiring Dec. 1, 2026) are being recalled. If the can’s code matches either of these, stop using it immediately and return or dispose of it. ByHeart has said it will replace recalled cans at no cost. (If you already threw out the formula, that’s fine – you can still contact ByHeart for a replacement if needed.)
For peace of mind, even if your baby seems well:
- Record the lot number (take a photo or write it down) before discarding or returning the can. This can be helpful information for health officials if they interview you or if any health concerns arise.
- Clean feeding equipment thoroughly. CDC recommends washing any bottles, nipples, or utensils that touched the recalled formula with hot, soapy water or in the dishwasher. Also wash surfaces that the formula may have contacted. (Boiling formula is not necessary and will not kill botulism spores – the recommended approach is simply to clean normally.)
- Choose a temporary alternative. While this batch is being looked at, you can safely use a different infant formula brand or a different ByHeart lot (if you have other unopened cans not in the recalled range). No other brand or lot has been implicated, so using another product poses no known risk.
- Stay informed. Watch for any updates from reliable sources like the FDA or CDC websites. ByHeart’s website and customer service (1-833-429-4327 or hello@byheart.com) are also available if you have questions about the recall.
Finally, if your baby consumed the recalled formula and then shows any worrisome symptoms (even if mild) in the coming days, seek medical care right away. The CDC specifically advises seeing a doctor if an infant fed the recalled formula has “poor feeding, loss of head control, difficulty swallowing, or decreased facial expression”. It’s better to err on the side of caution; doctors can perform simple tests (like stool sampling) to rule out infant botulism and administer antitoxin if needed.
Preventing Infant Botulism in the Future
While this recall is specific to one product, parents can take general steps to reduce any risk of infant botulism:
- Avoid honey – Never give honey (or foods containing honey) to a baby under 12 months. Honey is the classic source of Clostridium botulinum spores that cause infant botulism.
- Practice good cleanliness – Wash hands before handling a baby’s food or feeding equipment. Keep formula preparation areas clean and dry. While botulism spores are common in dust, routine cleaning (like vacuuming/sweeping and wiping surfaces) can limit unnecessary exposure.
- Prepare formula safely – Use safe water (boiled and cooled or bottled water as advised by your pediatrician). Follow the formula label instructions exactly (do not dilute improperly). While boiling prepared formula is not recommended (it won’t necessarily kill the spores and may concentrate toxins), proper mixing and prompt use/refrigeration of prepared bottles is good practice.
- Store formula properly – Keep unopened formula cans in a cool dry place. After opening or mixing, refrigerate bottles and use within the recommended time. Discard any formula that smells off or was improperly stored.
These habits are recommended for overall baby safety, even outside of botulism concerns. The only unique advice for botulism is really about honey (and, in this case, being alert to product recalls).
Treatment and Recovery
If infant botulism is confirmed, the standard treatment is hospitalization and administration of botulism immune globulin (BabyBIG®), which neutralizes the toxin. This antitoxin was developed by CDC’s California lab and is highly effective. All 13 infants in this outbreak received BabyBIG and are recovering. Recovery usually involves several days to weeks in the hospital until the toxin wears off and the baby regains muscle strength. Most children recover fully without lasting effects if treated early.
Given the seriousness of botulism, experts recommend treating any suspected case aggressively. In rare situations, infants may need respiratory support until they can breathe normally again. Again, no families in this outbreak suffered fatal outcomes thanks to prompt care.
Conclusion: Stay Calm and Stay Safe
Learning that “botulism” and “baby formula recall” are in the same headline can be frightening for parents. However, it’s important to remember: infant botulism is very rare, and officials are acting swiftly and cautiously to protect babies. According to CDC and FDA, this situation is unprecedented but the recall is limited and precautionary.
To recap the key points: A specific brand (ByHeart Whole Nutrition) has recalled two lots of powdered formula after 13 infants in several states got botulism and all had used that formula. There is no evidence that any other formula is affected. No formula-caused botulism has ever been proven before, and this product is only a tiny fraction of the market. Out of an abundance of caution, those cans are off the shelves while investigations continue.
If you have any of the recalled formula, stop using it now and follow recall instructions (note the lot code, discard it, contact the company if needed). Check on your baby’s health: if the baby seems completely normal, there’s likely nothing to worry about, but still watch for the signs listed above. If in doubt, talk to your pediatrician. Early care keeps infants safe.
For updates and more information, you can visit the FDA’s recall page or the CDC’s botulism outbreak advisory online. Health departments in many states (like Rhode Island and New York) have also posted guidance. Staying informed is the best way to protect your baby.
Above all, try to stay calm. This story is getting attention, but thousands of healthy babies are born every day without issues. By following these steps (checking product codes, cleaning well, and knowing the symptoms), you’ll be doing everything you can to keep your baby safe.
Key takeaways: Infant botulism is extremely rare; the formula recall covers only two specific lots of ByHeart Whole Nutrition powder; other formulas are safe. If you used the recalled formula, stop and clean up, then watch your baby closely. If any signs of illness appear, seek medical help immediately. Early treatment with the antitoxin is effective, and fortunately all infants in this outbreak are recovering.
For questions or concerns, you can also reach out to ByHeart’s customer support or check CDC’s Botulism website. The health and safety of infants is the top priority, and authorities are on the case.
Stay vigilant, follow recall guidelines, and consult your doctor with any concerns.
