No, only the two specific lots listed are part of this recall. The FDA investigation continues. If you're considering switching formulas regardless, consult with your pediatrician about the best approach for your baby's specific needs.
ByHeart Formula Recall 2025: What U.S. Parents Need to Know About Infant Botulism
By: Suzanne Renee' - November 14, 2025 - 12 Minute Read
ByHeart Recall 2025: What Parents Need to Know
On November 8, 2025, ByHeart voluntarily recalled two lots of its Whole Nutrition Infant Formula. The decision followeda CDC and FDA investigation into infant botulism cases that hospitalized 13 babies across 10 states since August CDC FDA. No deaths have been reported FDA.
If you're reading this, you probably found your way here because you're checking your formula cans right now. Maybe you're worried. Maybe you're frustrated that this keeps happening.
We get it. And we're here to help you understand what's actually going on, what you should do, and what options exist beyond what's on U.S. store shelves.
First: Check Your Formula
Recalled Lots
ByHeart recalled two specific batches with a "Use by 01 Dec 2026" date ByHeart:
● Lot: 206VABP/251261P2
● Lot: 206VABP/251131P2
Where to find it: Turn your can upside down. The batch code and use-by date are stamped on the bottom.
Understanding Infant Botulism
Infant botulism occurs when Clostridium botulinum spores colonize a baby's intestines and produce toxin. Early signs include constipation, feeding difficulties, a weak cry, and reduced muscle tone (CDC).
The important thing to know: symptoms can take several weeks to develop (CDC). If your baby consumed formula from these lots, monitor closely even if everything seems fine today.
What to Do Right Now
If you have ByHeart formula:
- Check your lotcode — Compare it to the two recalled batches
- Stop using it immediately if it matches
- Take a photo of the lot code before disposal
- Sanitize everything — Wash bottles, nipples, and any surfaces that contacted The formula (CDC)
- Monitor your baby — Watch for the symptoms listed above
- Contact your pediatrician — Especially if your baby consumed recalled lots
- Report to FDA —File a MedWatch report at accessdata.fda.gov/scripts/medwatch
Why Formula Recalls Keep Happening
This is the third significant U.S. formula recall in three years:
2022: Abbott/Similac recall led to nationwide shortages
2024: Similac hypoallergenic recall due to contamination concerns
2025: ByHeart botulism investigation
The core issue:
U.S. infant formula production is concentrated among a few large manufacturers operating massive facilities. While ByHeart represents less than 1% of the U.S. formula market and this recall won't create shortages (FDA), the pattern reveals something important about how American formula is made versus how it's made elsewhere.
The FDA has strengthened oversight since 2022. But the fundamental structure—high-volume centralized production—meansthat when problems occur, they affect a lot of families quickly.
Many parents are asking: what's the alternative?
Exploring other options?
Learn About European Formulas with Different Safety Standards
How European & Australian Formula Production Differs
European and Australian formula manufacturers operate under different production and regulatory models. Here's what sets them apart:
The European model prioritizes smaller production runs with extensive traceability. This doesn't guarantee perfection, but it does mean problems are typically identified and contained before affecting large populations.
Want the full breakdown? Read ourcomplete analysis: Why European Baby Formula Standards Differ
Three Formulas with Established Safety Records
Jovie Organic Goat (Netherlands)
Most Recommended for Transitions
EU Organic Certified
A2 goat milk protein (naturally easier to digest)
Natural prebiotics, palm oil-free
Available stages: 0-6m, 6-12m, 12+m
Best suited for: Babies with digestive sensitivity, families prioritizing organic standards, first-time formula switchers
Jovie Organic Cow (Netherlands)
Premium Cow Milk Option
EU Organic Certified
Grass-fed Dutch dairy
Pure lactose carbohydrate source
Available stages: 0-6m, 6-12m, 12+m
Best suited for: Families preferring cow milk formulas, parents seeking European organic standards
Sprout Organic Vegan (Australia)
Plant-Based Formula
Australian Certified Organic
Pea and brown protein blend
Coconut oil-based fats, soy-free
Available stages: 0-12m, 12+m
Best suited for: Vegan families, babies with cow milk protein allergy, dairy-free dietary needs
Other Quality Options:
HiPP Organic (Germany)—125+ year history, extensive testing protocols
Holle Organic (Switzerland)—Biodynamic farming practices
Nannycare Goat (New Zealand)—30+ year track record
Kabrita (Netherlands)—Clinically studied formulation
Complete formula comparison guide | Understanding goat milk formula
Why Parents Work with The Milky Box
We're a parent-founded company built around a simple principle: families deserve access to the formulas that meet the world's strictest standards.
What we do:
- We source our products directly from reputable and trusted suppliers across Europe and Australia.
- Complete lot traceability: Every can tracked from production to delivery
- International shipping handled: EU formulas ship from Europe
- Fresh inventory maintained: Minimum 6 months before expiration on all products
- Parent support team: Many of us use these formulas for our own children
- Customs compliance managed: All FDA import paperwork handled
- Satisfaction supported: If a formula doesn't work, we help you find one that does
Over 50,000 U.S. families have made the switch. See our complete vetting process
Formula Safety Best Practices
Regardless of which formula you choose, proper handling is essential:
Three-section guide:
STORAGE
✓ Store in cool, dry location (not refrigerated)
✓ Check expiration dates (European format: DD.MM.YY)
✓ Use opened containers within 3-4 weeks
✗ Never refrigerate powder (causes moisture and bacteria growth)
PREPARATION
✓ Wash hands thoroughly before each preparation
✓ Boil water and cool to appropriate temperature
✓ Follow exact mixing ratios from package instructions
✓ Use prepared bottles within 2 hours at room temperature
✗ Never reuse bottles baby has already drunk from
IMPORTANT REMINDERS
✗ Don't freeze formula (powder or prepared)
✗ Don't microwave bottles (creates dangerous hot spots)
✗ Don't save leftover milk from started bottles
✗ Don't use formula past expiration date
Additional resources: Formula storage guidelines | Proper preparation techniques | Understanding expiration dates | Why never to freeze formula
Transitioning to Toddler Formula
Common Questions About the ByHeart Recall 2025
Are other ByHeart lots affected by the recall?
How common are infant formula recalls?
Major recalls have occurred with some frequency in recent years—2022 (Abbott/Similac), 2024 (Similac hypoallergenic), and 2025 (ByHeart). European brands like Jovie and Sprout have maintained clean safety records during the same period, which is one reason many families explore imported options.
Is it legal to import European formula for personal use?
Yes. FDA regulations permit importationof infant formula for personal consumption without prior approval, providedit's for family use and not for resale CBPCustomer Service. The Milky Box manages all customs documentationand FDA compliance requirements.
What specific symptoms indicate infant botulism?
Watch for constipation (often the firstsign), weak sucking, droopy eyelids, reduced muscle tone, weak cry, anddifficulty swallowing. Symptoms can develop gradually over several weeks CDC. Contact your pediatrician immediately ifyou observe any of these signs.
How do babies adjust when switching formulas?
Most babies transition smoothly, particularly to gentler formulations like Jovie Goat. We recommend a gradual 7-day transition: begin with 25% new formula /75% current, progress to 50/50, then 75/25, and finally 100% new. Our support team has guided thousands of families through this process successfully.
What are typical shipping times?
European formulas ship directly from the EU and typically arrive within 2-5 business days via tracked & insured express shipping. We maintain a substantial inventory of all recommended brands.
Moving Forward with Confidence
The ByHeart recall of 2025 is a reminder that formula choice matters—not just for nutrition, but for peace of mind. Over 50,000 American families now source their formula through The Milky Box because they want:
- Formulas with clean safety records and transparent production
- Higher organic standards without compromise
- Smaller-batch manufacturing with better traceability
- Better digestibility that works for sensitive babies
- Confidence in what they're feeding their children
The transition typically takes about a week. Many parents tell us they wish they'd made the switch sooner.
Explore European Formulas
Explore Australian Formulas
Australian organic, complete plant-based nutrition
Questions about which formula is right for your baby?
Email: hello@themilkybox.com
Live chat: Available 7 days a week
Disclaimer:
Please be aware that this information is based on general trends in babies, and it is not medical advice. Your doctor should be your first source of information and advice when considering any changes to your child’s formula and when choosing your child’s formula. Always consult your pediatrician before making any decisions about your child’s diet or if you notice any changes in your child.
Breastfeeding is the best nutrition for your baby because breast milk provides your child with all the essential nutrients they need for growth and development. Please consult your pediatrician if your child requires supplemental feeding.
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Reviewed by Suzanne Renee',
Infant Nutrition Expert
Suzanne Renee' is an accomplished professional with extensive expertise in the area of infant nutrition, dedicated to promoting the health and wellbeing of children. She started this journey as a foster parent.
Suzanne has emerged as a strong proponent of the European baby formula and has become a full-time writer on the subject.
In her free time, she enjoys camping, hiking, and going to church.