6 things formula parents need to know about the botulism recalls
First, take a breath.
If you found this because of the Nara Organics recall, take a breath. The vast majority of babies who consumed affected products will be completely fine. Follow FDA and CDC guidance, discontinue use of recalled products, and contact your pediatrician with any concerns.
Within the past year, two premium infant formula brands—ByHeart in November 2025 and Nara Organics in June 2026—have faced recalls related to infant botulism concerns. The lesson isn't that formula companies are villains. It's that ingredient pathways matter.
As a human milk company, we believe parents deserve transparency about how infant feeding products are made. No feeding option is risk-free, but understanding where ingredients come from, how they're handled, and the environments they move through before reaching a baby's bottle provides important context for making informed decisions.
Real Donor Breast Milk, in a Single-Serve Sachet
Leche is 100% human donor breast milk, screened and triple-tested, then gently freeze-dried into pre-portioned 8g sachets. Each one makes a 2oz bottle in about 30 seconds. No bovine dairy, no thawing, no pumping. Just real breast milk, ready when you need it.
Affected by the recall?
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Here's what every formula parent should know:
What to Know #1
Two Organic Formula Brands Have Been Recalled in Six Months
Two Organic Formula Brands Have Been Recalled in Six Months
Two brands, two recalls, six months apart. ByHeart expanded to all products in November 2025 as cases reached about 48 infants across 17 states. Nara Organics pulled all lots in June 2026 after three infants in three states got sick. Every affected baby was hospitalized, no deaths were reported, and there is no formula shortage.
It’s worth saying: formula companies are not villains. Recalling everything quickly is a company trying to protect families.
What to Know #2
Infant Botulism Is Rare and Treatable, but Worth Understanding
Infant Botulism Is Rare and Treatable, but Worth Understanding
A baby swallows dormant spores of Clostridium botulinum, and an immature gut lets them grow and release a toxin that affects the nerves. Watch for constipation, weak feeding, a weak cry, droopy eyelids, and loss of head control. It can take days to weeks to appear.
The reassuring part: it's rare, there's an FDA-approved treatment (BabyBIG), and no deaths were reported in either outbreak.
What to Know #3
The Spores Come From The Environment, Not Bad Manufacturing
The Spores Come From The Environment, Not Bad Manufacturing
Those spores live in soil and dust. It is the same reason babies under one should never have honey. So this is not a factory, it is an environment story: a careful company can still be affected by what its ingredients picked up long before manufacturing started.
What to Know #4
The Risk Traveled In On The Ingredient, Not The Factory Floor
The Risk Traveled In On The Ingredient, Not The Factory Floor
Premium formulas are built around organic whole milk powder, a minimally processed, farm-sourced dairy ingredient from cows in direct contact with soil and dust. In the ByHeart outbreak, genetic sequencing tied the bacteria to that whole milk powder. The risk rode in on the ingredient, not the factory floor, so the biggest safety choice happens before manufacturing: which ingredient you start with.
Where Leche Fits: It never uses that ingredient. Leche starts with screened human milk, not farm-sourced dairy powder.
What to Know #5
You Cannot Reliably Destroy Botulism, So The Starting Ingredient Matters Most
You Cannot Reliably Destroy Botulism, So The Starting Ingredient Matters Most
No heating or drying step in any milk powder reliably destroys botulism spores, and routine testing for them was not standard. Testing has improved, and brands like Nara Organics now screen every batch, which is good. But testing is a backstop. The real lever is starting with an ingredient that never travels the soil-to-farm-to-powder path.
Where Leche Fits: Our safeguard is the starting ingredient itself, backed by testing at every stage.
What to Know #6
Powdered Donor Milk Sits Outside This Specific Risk
Powdered Donor Milk Sits Outside This Specific Risk
Human donor milk follows a fundamentally different ingredient pathway. Unlike formula, it does not begin with bovine (cow-derived) dairy ingredients. Instead, it starts with milk from medically screened human donors. That removes the agricultural dairy pathway that was identified in the ByHeart recall and is being investigated in the Nara Organics recall.
The Honest Caveat: No infant feeding product is risk-free, and no manufacturing process—including ours—should rely on a single "magic" step to eliminate every potential risk. That's why our approach starts upstream. We avoid the higher-risk dairy ingredient pathway, medically screen every donor, and conduct rigorous testing throughout the process—from incoming milk to finished product—so safety is built into every stage, not left to chance at the end.
How We Built Leche Differently
We know donor milk only works if you trust it.
So trust is the thing we build everything around.
How We Built Leche Differently
We know donor milk only works if you trust it.
So trust is the thing we build everything around.
- No bovine dairy pathwayThe farm-sourced dairy ingredient at the center of these recalls simply isn't in our product. We don't start with cow-derived milk.
- Rigorous medical screeningApplication, medical history, and blood tests confirm every donor's eligibility before any milk enters our process.
+ See everything we screen for - Dedicated human-milk facilityProcessed in an FDA-registered facility that handles human milk only. No shared dairy lines, no cross-over.
- Triple-tested + third-party verifiedTested before and after pasteurization, again after freeze-drying, plus independent lab verification on every lot.
None of this makes us invincible. It makes us careful, transparent, and verified, and we would rather promise that honestly than oversell it.
- No bovine dairy pathwayThe farm-sourced dairy ingredient at the center of these recalls simply isn't in our product. We don't start with cow-derived milk.
- Rigorous medical screeningApplication, medical history, and blood tests confirm every donor's eligibility before any milk enters our process.
+ See everything we screen for - Dedicated human-milk facilityProcessed in an FDA-registered facility that handles human milk only. No shared dairy lines, no cross-over.
- Triple-tested + third-party verifiedTested before and after pasteurization, again after freeze-drying, plus independent lab verification on every lot.
If you're affected by the Nara recall, here's what to do right now
A quick checklist while you talk with your pediatrician.
- Stop using any Nara Organics whole milk organic infant formula immediately, all lots and sizes.
- Do not throw it out reflexively. The FDA advises keeping leftover product somewhere safe, away from other food, clearly marked “do not use,” because state health officials may request samples for testing. Photograph the lot code on the bottom of the can. You will want it for your refund anyway.
- Watch your baby for up to a month after the last feeding for signs like constipation, poor feeding, a weak cry, droopy eyelids, or loss of head control, and call your pediatrician right away if you see them.
- Clean bottles and surfaces that touched the formula with hot soapy water or the dishwasher.
- Switch to another formula in the meantime. There is no shortage, and your pediatrician can help you choose.
- Get your refund. Nara is refunding purchases made directly on nara.com in May and June 2026. For other purchases, submit a photo of the lot code through Nara's refund form. Bought it at Target? Return it to any Target store.
So what are your options right now?
supplement your feeding journey
powdered donor breast milk
Leche is 100% human donor breast milk powder from medically screened donors, triple-tested at every stage for safety and quality, processed in an FDA-registered facility following GMP guidelines. Each convenient 8g sachet reconstitutes into 2oz of breast milk, making it easier and safer to access donor milk.
Single Ingredient
HMOs: natural NOT manufactured
No Seed Oils
No Preservatives
Ready in 30 seconds
💛 If the recall brought you here, use code SUPPORT30 and get 30% off at checkout.
Our way of helping while you talk with your pediatrician and choose what's next.
Most Asked Questions From Parents Like You.
The primary reason for urging the use of human donated milk is centered around nutritional value. Human milk is easier for a premature baby to digest and contains essential fats that are crucial to the development of the baby's brain and neurologic tissues. Formula is generally a processed (and sometimes fortified) form of cow's milk. Many premature and low-birth-weight infants, whose digestive systems may not be fully formed, have a difficult time processing the proteins in cow's milk, and may develop intestinal infections as a result.
All donors undergo a rigorous medical screening process including application review, medical history evaluation, and blood testing before being approved.
Yes. Freeze-drying is performed after pasteurization, preserving the nutritional profile while removing moisture to ensure shelf stability.
Leche is 100% human breast milk with no additives. Please consult your pediatrician if your baby has known allergies or sensitivities.
Yes. Leche is made from 100% donated human breast milk. There are no cow's milk derivatives, no synthetic additives, and no formula ingredients.
Absolutely. Leche is designed to complement your own supply, not replace it.
You can order directly from our website. Subscriptions and one-time purchases are both available.
It is a different risk profile, not a safety ranking. donor milk avoids the farm-sourced dairy ingredient the outbreaks were traced to, but it still has to be screened and tested, and it is not a cost-equivalent full replacement for most families.
In theory any food can pick up environmental spores, which is why screening and batch testing matter. But human milk does not come from the soil-exposed bovine dairy-powder supply chain the outbreaks were tied to.
Not reliably. The spores resist heat and drying, true for formula powder and donor milk powder alike. It is why we focus on the ingredient and on testing every batch, not on one processing step.
No. both brands together are a tiny share of the U.S. market, and officials have not flagged shortage concerns.
We do not think so. ByHeart owned its facilities and recalled quickly, and Nara was already screening every batch. This is a category-wide lesson the whole industry is absorbing, ourselves included.