ByHeart Formula Review: How It Compares to HiPP and Kendamil in 2026

If you’re reading this, most likely you’re a former ByHeart customer trying to figure out what happened and what to do now. ByHeart formula built a real following fast after launching in 2022. ByHeart baby formula used whole milk protein and lactoferrin, positioned as the first genuinely new US formula in decades, science-driven and premium.

Then, in November 2025, a multistate infant botulism outbreak was traced back to ByHeart infant formula. News of the ByHeart botulism cases spread fast, and the company pulled every product it had ever made off shelves. Forty-eight babies were hospitalized. Production is still paused. If you used to buy this ByHeart infant formula or are comparing formulas now, this ByHeart formula review walks through what happened, where things stand, and how HiPP and Kendamil compare as alternatives.

This article is for general informational purposes and isn’t medical advice. Every recall fact below comes straight from FDA.gov and CDC.gov. If your baby has had ByHeart formula and shows any signs of infant botulism (constipation, trouble feeding, a weak cry, losing head control), please get medical care right away rather than waiting to see if it passes.

What Is ByHeart Formula? Origin, Ingredients, and Brand Philosophy

ByHeart started in 2022 as a US infant nutrition startup, founded on the idea that formula hadn’t really been reinvented in decades. Manufacturing of ByHeart Whole Nutrition Infant Formula was carried out at two facilities, one in Portland, Oregon, and one in Allerton, Iowa.

The core of ByHeart’s formula ingredients was whole milk protein with a whey-to-casein ratio closer to breast milk, plus lactoferrin, 2’-FL HMO, and DHA/ARA, using organic ingredients where available. Those ByHeart formula ingredients were the whole pitch: a premium, US-made formula priced around $40 or more per can, sold direct and through Target, Amazon, Whole Foods, and Sprouts. At its peak, the brand held roughly 1% of the US formula market, a detail that mattered once the outbreak numbers came in.

The 2025 ByHeart Recall: A Complete Timeline of the Botulism Outbreak

Here’s exactly how it unfolded, pulled from CDC and FDA reporting:

• August 2025: California’s Infant Botulism Treatment and Prevention Program noticed a nationwide uptick in infant botulism cases.

• November 7, 2025: The FDA flagged a possible link between those cases and the formula.

• November 8, 2025: ByHeart voluntarily recalled two specific lots.

• November 11, 2025: The recall widened to every ByHeart Whole Nutrition Infant Formula product ever made, cans and Anywhere Pack sticks included, since the FDA couldn’t rule out contamination across the brand’s full production history.

• Ongoing review: Case tracing eventually reached illness onset dates as far back as December 2023, well before anyone was looking in August 2025, which is why the recall covers everything the brand ever produced.

• December 23, 2025: Independent lab testing confirmed Clostridium botulinum, the bacterium behind ByHeart botulism, in several finished product samples, traced to organic whole milk powder from a third-party supplier.

• February 26, 2026: CDC and FDA officially declared the outbreak closed. Final tally: 48 confirmed infants hospitalized across 17 states, all treated with BabyBIG, a specialized antitoxin. No deaths were reported.

Worth knowing if you’re a former customer: recalled cans reportedly remained on some shelves for weeks after the recall was issued. If you have any ByHeart at home, it’s worth checking rather than assuming it’s fine.

ByHeart’s Response and 2026 Status: Where the Company Stands Today

ByHeart moved fast once the FDA flagged the problem: recalled within 24 hours of that first notification, expanded within days, halted production, and brought in independent lab testing to help pin down the source.

On June 3, 2026, the FDA finished on-site inspections of both facilities and found no deficiencies in ByHeart’s own manufacturing that explained the outbreak. The investigation keeps pointing to that third-party milk powder supplier instead. Going forward, every dairy ingredient and finished batch will be tested specifically for C. botulinum before shipping.

Right now, production is still paused with no confirmed return date. Every honest ByHeart formula review roundup since the recall lands in the same place: you simply can’t buy ByHeart baby formula right now, and no fair ByHeart review can recommend something that isn’t on shelves and is still mid-overhaul on safety. Reading older ByHeart formula reviews against anything written post-recall makes that shift obvious.

ByHeart vs HiPP vs Kendamil: The Complete Comparison

Recent safety events 2025 botulism recall (48 infants); earlier FDA warning letter No major recalls Minor Canada cereulide recall, resolved Jan to Feb 2026

ByHeart vs HiPP: The European Combiotic Alternative

ByHeart vs Kendamil  is the comparison most former customers want. Still, HiPP deserves a look too, especially if the science-forward positioning drew you in more than just the whole milk. ByHeart leaned on lactoferrin and HMO on a US whole-milk base. HiPP takes a different approach: GOS prebiotics paired with an L. fermentum probiotic strain, EU Organic certification with genuinely strict residue and GMO rules, and lactose-only carbs designed to mirror breast milk.

HiPP uses skim milk and whey rather than whole milk and leans on beta-palmitate (structured palm oil) rather than skipping palm oil, as Kendamil does. What HiPP brings that neither of the other brands can match is a century-plus of manufacturing history with no major US recalls and the broadest specialty lineup, including HA, Comfort, and AR formulas. It reaches US families through specialty importers like Organic Life Start, usually within 5 to 10 days.

ByHeart vs Kendamil: The Closest Philosophical Match

Of the two, Kendamil vs ByHeart is the more natural pairing, and it’s the question we hear most from people in your spot. Both brands built their identities around whole milk rather than vegetable oil blends, and both launched as modern, clean-label, premium picks for parents who wanted better than legacy US brands.

Here’s where Kendamil pulls ahead right now: FDA-registered for US retail since March 2024, sitting on shelves today at Target, Amazon, and Whole Foods, no palm oil across any line, and available in both organic (EU Organic plus British Soil Association) and non-organic versions, backed by more than 60 years in business.

The real difference: ByHeart added lactoferrin and 2’-FL HMO, which Kendamil’s main lines skip. Kendamil counters with naturally occurring MFGM straight from whole milk, a genuinely palm-oil-free fat blend, and, what matters most right now, an actual clean safety record. Kendamil runs about $30 to $35 a can, a bit less than ByHeart’s $40-plus. Kendamil’s own safety history is one minor, already-resolved cereulide recall in Canada in January and February 2026, nowhere near the scale of what happened here.

If you’re looking for the closest ByHeart alternative, our Kendamil collection is the closest match: whole milk, palm-oil-free, premium, and in stock. Prefer the European combiotic route? Our HiPP formula collection covers that range.

ByHeart had something genuinely good going, and once it found out something was wrong, it moved quickly and did the right things. That doesn't change where things stand: the formula isn't available, and your baby needs to eat now. Kendamil is the closest fit if whole milk and a currently clean record matter most. HiPP is the stronger pick if you're drawn to the European combiotic philosophy instead. Our baby formula quiz can help you land on the right one.