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Is ByHeart Formula Good? (2026 Safety Update)

📅 Updated February 2026⏱️ 4 min readNEW

TL;DR

Do not buy or use ByHeart infant formula. The company issued a total product recall in November 2025 after their formula was linked to a nationwide infant botulism outbreak. In January 2026, the FDA confirmed their organic whole milk powder was the source of the deadly contamination.

🔑 Key Findings

1

51 infants across 19 states have been hospitalized with botulism linked to ByHeart.

2

The FDA confirmed the contamination came from the formula's organic whole milk powder in January 2026.

3

The Clean Label Project suspended ByHeart's prestigious "Purity Award" certification following the outbreak.

4

Target and Walmart received FDA warning letters for illegally keeping the recalled formula on shelves into December 2025.

The Short Answer

Throw away any ByHeart formula immediately. Once considered one of the highest-quality premium formulas on the market, ByHeart is currently under a total nationwide recall.

In November 2025, an unprecedented outbreak of infant botulism was linked directly to ByHeart products. As of early 2026, 51 babies have been hospitalized. The FDA has officially confirmed that the Clostridium botulinum bacteria entered the formula through a contaminated batch of organic whole milk powder from one of ByHeart's suppliers.

Why This Matters

Infant botulism is incredibly rare but extremely dangerous. It attacks a baby's nervous system and can cause respiratory failure. Because an infant's digestive tract is immature, it cannot fight off the botulism spores before they release deadly toxins.

This recall shattered the illusion that premium certifications guarantee safety. ByHeart held the prestigious Clean Label Project Purity Award, which tests for heavy metals and pesticides. However, this certification was suspended after the recall because it does not test for deadly biological pathogens like botulism. Heavy Metals Baby Formula

Retailer negligence made the situation worse. Major chains like Target and Walmart received FDA warning letters because they continued selling the recalled formula weeks after the ban. You cannot trust that the formula on your local shelf is safe—you must actively monitor Baby Formula Recalls.

What's Actually In ByHeart Formula

Before the recall, ByHeart was praised for its ingredient profile. Here is what is inside, and where things went wrong:

  • Organic Grass-Fed Whole Milk — This provided excellent natural fats for brain development. Tragically, this was the exact ingredient that carried the botulism spores.
  • Alpha-Lactalbumin & Lactoferrin — These premium proteins mimic breast milk to aid digestion and immune support. Closest To Breast Milk
  • Lactose — ByHeart uses 100% lactose as its carbohydrate, meaning there are zero processed corn syrup solids. Corn Syrup Baby Formula
  • Algal Oil DHA — They use a plant-based omega-3 source that is sustainably harvested and extracted without harsh chemical solvents. Hexane Extracted Dha

What to Look For

If you are looking for a replacement for ByHeart, keep these factors in mind.

Green Flags:

  • Whole milk fats — Kendamil is an excellent alternative that uses whole milk fat instead of processed vegetable oils.
  • Lactose-based — The closest carbohydrate to human breast milk.
  • Stringent supplier testing — Look for brands that mandate third-party pathogen testing on raw ingredients before manufacturing. Is Formula Fda Regulated

Red Flags:

  • Palm oil — Can cause harder stools and decrease calcium absorption in infants. ByHeart famously avoided this. Palm Oil Baby Formula
  • Recalled batches — Never assume a store pulled a recalled item. Always check the lot numbers yourself.

The Best Options

With ByHeart entirely off the market, parents who want premium, European-style nutrition need safe alternatives.

BrandProductVerdictWhy
BobbieOrganic Infant FormulaSpotless safety record and rigorous EU-style recipe. Is Bobbie Good
KendamilOrganic First Infant MilkThe best whole milk alternative with zero palm oil.
ByHeartWhole Nutrition Formula🚫100% recalled due to life-threatening botulism contamination.

The Bottom Line

1. Stop using ByHeart immediately. All batches, cans, and travel packs have been recalled.

2. Watch for botulism symptoms. If your baby shows signs of constipation, poor feeding, weak crying, or lethargy, go to the emergency room immediately.

3. Get your refund. ByHeart is offering full refunds for any purchases made since August 2025 through their website or your local retailer.

FAQ

Can I get a refund for my ByHeart formula?

Yes, ByHeart is offering full refunds. If you purchased directly from their website after August 1, 2025, you can contact their customer service. If you purchased at retail, you must return the product to the store for a refund.

Is Bobbie formula safer than ByHeart?

Right now, absolutely. Bobbie has maintained an excellent safety record and uses a rigorous manufacturing process that has never been linked to a pathogen outbreak. Bobbie Vs Byheart

Will ByHeart formula come back?

Eventually, but trust will be hard to rebuild. The company has paused all production to overhaul its supply chain and implement mandatory third-party botulism testing on every single ingredient before it enters their facility.


References (17)
  1. 1. healthbeat.org
  2. 2. byheart.com
  3. 3. healthbeat.org
  4. 4. aha.org
  5. 5. pregnantchicken.com
  6. 6. organiclifestart.com
  7. 7. govdelivery.com
  8. 8. byheart.com
  9. 9. fda.gov
  10. 10. fda.gov
  11. 11. byheart.com
  12. 12. nutritioninsight.com
  13. 13. prnewswire.com
  14. 14. healthbeat.org
  15. 15. byheart.com
  16. 16. byheart.com
  17. 17. fredmeyer.com

🛒 Product Recommendations

Bobbie Organic Infant Formula

Bobbie

A rigorous European-style organic formula manufactured in the US with an excellent safety record.

Recommended
Kendamil Organic First Infant Milk

Kendamil

The best whole milk alternative to ByHeart, boasting a spotless safety history and organic European ingredients.

Recommended
🚫
ByHeart Whole Nutrition Infant Formula

ByHeart

All batches are currently recalled due to life-threatening Clostridium botulinum contamination.

Avoid

Holle Bio Stage 1 (Cow Milk)

Holle

This German formula meets Demeter biodynamic standards, the highest tier of organic certification globally. It uses simple ingredients with no palm oil, soy, or corn syrup, relying purely on organic lactose for carbohydrates.

Recommended
HiPP Dutch Stage 1

HiPP

A favorite among health-conscious parents for its inclusion of both prebiotics (GOS) and probiotics (Lactobacillus fermentum) to support infant gut health. It is 100% lactose-based and free from starch and maltodextrin found in other versions.

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Kabrita Goat Milk Infant Formula

Kabrita

Now fully FDA-authorized for infants, this formula uses Dutch goat milk which naturally forms a softer curd in the stomach for easier digestion. It is Certified Glyphosate Residue Free and contains no corn syrup solids.

Recommended

Nara Organics Whole Milk Infant Formula

Nara Organics

A newer US brand manufactured in Germany that distinguishes itself by using organic whole milk as the primary ingredient rather than skim. It holds the Clean Label Project Purity Award and contains zero palm oil or soy allergens.

Recommended
Aussie Bubs Grass Fed Nutritional Formula

Aussie Bubs

Sourced from Australian grass-fed cows, this formula holds the Clean Label Project Purity Award. It uses a high-quality fat blend that completely excludes palm oil, promoting better calcium absorption.

Recommended

Jovie Organic Goat Milk Formula

Jovie

Uses organic whole goat milk as the first ingredient, retaining natural milk fats that many other brands skim off. It is completely free of palm oil and soy oil, using sunflower and rapeseed oils instead.

Recommended
👌

Pure Bliss by Similac

Similac

The best mainstream option available at major retailers, sourced from fresh Irish milk rather than reconstituted powder. Unlike standard Similac, it contains no palm olein oil and no corn syrup, using lactose as the sweetener.

Acceptable
👌

Else Nutrition Infant Formula

Else Nutrition

A unique plant-based alternative made from almonds, buckwheat, and tapioca for families avoiding dairy and soy. It is Clean Label Project certified and free from chemical processing, though it lacks the animal proteins found in breast milk.

Acceptable
Baby's Only Organic Premium Infant Formula

Baby's Only

Recently receiving FDA approval for infants, this formula has moved away from its toddler-only roots. It is lactose-based (no syrup solids) and has earned the Clean Label Project Purity Award for low heavy metal content.

Recommended
👌

Kirkland Signature ProCare

Kirkland (Costco)

An incredible value that avoids the common pitfall of palm olein oil, which can cause constipation. It is non-GMO and uses lactose as the primary carbohydrate, making it superior to many expensive name brands.

Acceptable

HiPP HA (Hypoallergenic) Stage 1

HiPP

Unlike American hypoallergenic formulas that rely on corn syrup, this German option uses hydrolyzed whey protein while retaining lactose as the carbohydrate. It is the gold standard for babies with cow milk protein sensitivity who do not need an amino acid formula.

Recommended
👌

Happy Baby Organic Infant Formula

Happy Baby

A widely available organic option that includes a dual prebiotic blend (GOS and FOS). While it contains soy oil, it avoids corn syrup solids and uses organic lactose, making it a solid mid-range choice.

Acceptable
🚫

Enfamil NeuroPro Gentlease

Enfamil

The very first ingredient is corn syrup solids, meaning your baby is consuming a highly processed sugar as their primary food source. It also relies on palm olein oil, which is linked to harder stools and reduced calcium absorption.

Avoid
🚫
Similac 360 Total Care Sensitive

Similac

Marketing terms like 'Sensitive' often mask poor ingredients; here, the first ingredient is corn syrup and it explicitly lists 'Sugar' on the label. It replaces nutrient-dense lactose with cheap sweeteners.

Avoid
🚫

Gerber Good Start SoothePro

Gerber

The primary ingredient is corn maltodextrin, a processed filler carbohydrate. While it uses hydrolyzed whey for digestion, the carbohydrate source is nutritionally inferior to lactose.

Avoid
⚠️

Nutramigen with Enflora LGG

Enfamil

While necessary for severe allergies, it is comprised of 48% corn syrup solids. Only use this if a medical professional confirms your baby cannot tolerate the hydrolyzed lactose in cleaner alternatives like HiPP HA.

Use Caution
🚫
Parent's Choice Gentle

Walmart

A generic formulation where corn syrup solids appear as the first ingredient. While it meets FDA minimums, it lacks the premium fats and lactose base required for optimal development.

Avoid
⚠️

Baby's Only Organic Sensitive Toddler

Baby's Only

Unlike their premium infant formula, this 'Sensitive' version uses organic brown rice syrup. Brown rice syrup has historically been flagged for higher arsenic levels compared to other carbohydrate sources.

Use Caution
⚠️

Enfamil Enspire

Enfamil

Despite being marketed as their closest formula to breast milk due to added lactoferrin, it still uses palm olein oil. For the premium price point, superior fat blends without palm oil are available.

Use Caution
🚫

Similac Soy Isomil

Similac

Combines corn syrup solids with soy protein isolate. Soy-based formulas contain high levels of phytoestrogens and should generally be avoided unless the infant has a specific medical contraindication to all dairy and hydrolyzed options.

Avoid
⚠️

Burt's Bees Baby Organic

Burt's Bees

Although organic, this formula includes palm oil in its fat blend. While legally permitted, palm oil can form calcium soaps in the gut, potentially leading to constipation and lower mineral absorption.

Use Caution
⚠️

Earth's Best Organic Sensitive

Earth's Best

The 'Sensitive' label indicates the removal of lactose in favor of corn syrup solids. Unless your baby has a diagnosed lactase deficiency (which is rare in infants), lactose is the preferred carbohydrate.

Use Caution
⚠️

Pepticate

Nutricia

A hypoallergenic option that correctly uses lactose instead of corn syrup, but unfortunately relies on a fat blend containing palm oil. It is better than Nutramigen but falls short of the palm-free standard set by brands like HiPP HA.

Use Caution

💡 We don't accept payment for recommendations. Some links may be affiliate links.

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