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2026 Baby Formula Recalls

2026 has already seen the fallout from the largest formula safety events in recent history — a US botulism recall and a global contamination crisis spanning 60+ countries.

Here's what happened, what's affected, whether your formula is involved, and what you should actually do. Facts first, panic never.

The Big Picture: What's Happening in 2026

2026 has started with two of the largest infant formula safety events in recent history happening simultaneously. Both are serious. Neither should make you panic.

The first is the continuation of the ByHeart botulism recall — the first known infant botulism outbreak linked to formula in the world. All ByHeart products ever manufactured remain recalled. No new cases have been reported since December 2025. The investigation is ongoing but the immediate crisis appears to be stabilizing.

The second is a massive global cereulide contamination crisis that has triggered recalls across 60+ countries, affecting Nestlé, Danone, Lactalis, and other manufacturers. This one is primarily a European and international issue — the affected brands are not sold in US retail stores. But if you import European formula, you need to know about it.

Here's what matters for US parents: the US formula supply on store shelves (Similac, Enfamil, Gerber, Bobbie, Kendamil, Kirkland, and other FDA-regulated brands) has not been affected by the cereulide crisis. The ByHeart recall is the only active US FDA formula recall as of February 2026, and ByHeart represented approximately 1% of US formula sales — no supply shortage has occurred.

2026 Formula Recall Events at a Glance
ByHeart Botulism Recall (ongoing)
StatusActive — all product recalled
ClassificationClass I
Affects US?Yes — US FDA recall
DetailsAll ByHeart Whole Nutrition Infant Formula ever produced remains recalled. 51 infants hospitalized across 19 states with infant botulism. Clostridium botulinum confirmed in finished product and organic whole milk powder ingredient. FDA issued warning letters to Walmart, Target, Kroger, and Albertsons for failing to remove product from shelves. As of Jan 23, 2026 CDC update: no new cases since Dec 1, 2025. No deaths reported.
Global Cereulide Crisis (Nestlé, Danone, Lactalis)
StatusActive — recalls in 60+ countries
ClassificationVaries by country
Affects US?No — primarily EU/international brands
DetailsCereulide toxin contamination traced to a single Chinese ARA oil supplier (Cabio Biotech). Nestlé recalled 800+ products from 10+ factories across 60+ countries. Danone recalled Aptamil and Cow & Gate products. Lactalis recalled in 18 countries. Affected brands (SMA, NAN, BEBA, Aptamil, Cow & Gate) are not sold in US retail. UK reported 36 clinical cases. French prosecutors investigating 5 companies. Deaths of 2–3 infants under investigation in France (no causal link established). Estimated $1.3B financial exposure for Nestlé.
Kendamil Recall (Canada)
StatusActive — CFIA recall
ClassificationN/A (Canadian, not FDA)
Affects US?No — Canadian recall only (Costco Canada)
DetailsCanadian Food Inspection Agency recalled Kendamil Whole Milk Infant Formula sold at Costco Canada for potential cereulide toxin. Two lot codes affected. Same root cause as global cereulide crisis — contaminated ARA oil from the same Chinese supplier. No illnesses reported. No US FDA recall issued for Kendamil.
FDA Retailer Warning Letters
StatusEnforcement action
ClassificationN/A
Affects US?Yes — US enforcement
DetailsFDA sent formal warning letters to Walmart, Target, Kroger, and Albertsons in December 2025 for failing to remove recalled ByHeart formula from shelves. FDA investigators found recalled product in 175+ locations across 36 states, in some cases for over 3 weeks after the recall. Recalled product was found for sale as recently as January 18, 2026.
This table reflects publicly available data as of February 26, 2026. Check FDA.gov and manufacturer websites for the most current information.

The ByHeart Recall: 2026 Update

The ByHeart infant botulism outbreak was the defining formula safety event of late 2025, and its aftermath has carried into 2026. Here is where things stand.

The CDC's most recent update (January 23, 2026) shows the case count holding steady at 51 hospitalized infants across 19 states. No new cases have been reported since December 1, 2025. No deaths have been attributed to the outbreak.

The root cause has been identified: Clostridium botulinum was confirmed in finished product samples and traced via genetic sequencing to organic whole milk powder — an ingredient sourced from a supplier that does not supply other formula manufacturers. ByHeart has paused all production, marketing, and influencer partnerships.

The most troubling part of the ByHeart story in 2026 is not the contamination itself — it's the retail response. The FDA found recalled ByHeart formula still on store shelves in 175+ locations across 36 states, in some cases for over three weeks after the recall was announced. Recalled product was found for sale as recently as January 18, 2026 — more than two months after the public warning. The FDA issued formal warning letters to Walmart, Target, Kroger, and Albertsons.

If you have any ByHeart formula at home — any lot number, any product — do not use it. The entire brand's production history is recalled.

ByHeart Recall: Key Facts (Updated Feb 2026)
Total cases
Details51 infants hospitalized across 19 states (AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, WI)
Deaths
DetailsZero deaths reported as of February 2026
Last new case
DetailsDecember 1, 2025 — no new cases reported since (per Jan 23, 2026 CDC update)
Recall scope
DetailsAll ByHeart Whole Nutrition Infant Formula ever produced — cans and single-serve packs — since the brand launched in March 2022
Root cause
DetailsClostridium botulinum confirmed in 6 of 36 finished product samples. Genetic sequencing matched contamination to organic whole milk powder from a ByHeart supplier. The supplier does not supply other formula manufacturers.
Production status
DetailsByHeart has paused all production, marketing, advertising, and influencer partnerships
Retailer enforcement
DetailsFDA issued warning letters to Walmart, Target, Kroger, and Albertsons. Recalled product found on shelves in 175+ locations across 36 states. Product found for sale as recently as January 18, 2026.
Congressional scrutiny
DetailsSenator Cassidy wrote to ByHeart citing FDA inspection reports of 'numerous safety deficiencies' in manufacturing facilities
Source: FDA, CDC, and ByHeart public statements. No new cases have been reported since December 1, 2025.

The Global Cereulide Crisis: What US Parents Need to Know

This is the biggest infant formula safety event of 2026 by geographic scope — and it's one that most US parents haven't heard about, because it primarily affects brands sold outside the United States.

In late November 2025, Nestlé detected cereulide — a heat-stable toxin produced by Bacillus cereus bacteria — during routine testing at its factory in the Netherlands. By January 2026, the recall had expanded to 60+ countries and 800+ products. Austria's Health Ministry called it the largest recall in Nestlé's history.

Then it spread beyond Nestlé. Danone, Lactalis, and smaller brands all issued recalls after confirming they had sourced the same contaminated ingredient: arachidonic acid (ARA) oil from a single Chinese supplier, Cabio Biotech. ARA is added to formula for brain and eye development. Lab analysis revealed the contamination dates back to at least October 2024 and persisted throughout 2025.

The affected brands — SMA, NAN, BEBA, Aptamil, Cow & Gate — are not sold in US retail stores. They are regulated by European and international food safety authorities, not the FDA. No US FDA recall has been issued for these products.

But this matters for US parents in two specific scenarios. First, if you import European formula (HiPP, Aptamil, Holle, or others), you should check whether your products are affected — you are outside the FDA recall system and responsible for monitoring European safety alerts yourself. Second, Kendamil — a UK brand that is sold in the US — was recalled in Canada for the same cereulide contamination. No US FDA recall has been issued for Kendamil, but the situation is evolving.

Global Cereulide Crisis: Timeline
Late Nov 2025
What HappenedNestlé detects low levels of cereulide during routine checks at its Nunspeet, Netherlands factory after installing new production equipment
Dec 10, 2025
What HappenedNestlé informs Dutch food safety authorities and the European Commission. Initial voluntary recall issued.
Jan 5, 2026
What HappenedNestlé begins public voluntary recall across multiple countries after extensive lab analysis (Dec 23, 2025 – Jan 3, 2026)
Jan 12, 2026
What HappenedRecall expands to 50+ countries. Austrian Health Ministry calls it the largest recall in Nestlé's history — 800+ products from 10+ factories
Jan–Feb 2026
What HappenedDanone, Lactalis, and smaller brands (Babybio, La Marque en Moins) issue precautionary recalls after confirming they sourced ARA oil from the same Chinese supplier (Cabio Biotech)
Feb 2, 2026
What HappenedEFSA proposes first-ever safety threshold for cereulide in infant formula (0.014 μg/kg bodyweight). Prior to this date, no generally accepted limit existed.
Feb 13, 2026
What HappenedSeven EU countries (Austria, Belgium, Denmark, France, Luxembourg, Spain, UK) report infants with gastrointestinal symptoms under investigation
Feb 16, 2026
What HappenedFrench prosecutors open criminal investigations into five formula companies
Feb 22, 2026
What HappenedCanada's CFIA recalls Kendamil infant formula sold at Costco Canada for cereulide — same ARA oil supplier as the global crisis
Feb 23, 2026
What HappenedNestlé reports CHF 185 million ($210M) financial hit. Analysts estimate up to $1.3 billion total exposure. Both Nestlé and Danone warn of Q1 earnings impact.
This timeline reflects publicly available reporting as of February 26, 2026. The investigation is ongoing across multiple countries. French prosecutors are investigating five formula companies.

What Is Cereulide? (And Why It's Different)

Cereulide is different from the contamination events US parents are used to hearing about. Cronobacter and Salmonella — the bacteria behind previous major US formula recalls — can be managed through proper preparation (using hot water, cleaning bottles). Cereulide cannot.

You cannot cook it out

Cereulide is heat-stable. Boiling, microwaving, or any preparation method will not neutralize it. Once it is in the formula powder, it stays. This is why the recalls are so broad — there is no consumer workaround.

It came from the supply chain, not the factory

The contamination entered through ARA oil from a single Chinese supplier. Multiple formula manufacturers — Nestlé, Danone, Lactalis, Kendamil — sourced from this supplier. This is a supply chain vulnerability, not a single-factory failure.

There was no safety limit before 2026

Prior to February 2, 2026, there was no generally accepted regulatory limit for cereulide in infant formula. The European Food Safety Authority proposed the first-ever threshold only after this crisis forced the issue. That gap meant manufacturers were not testing for a risk that no one had defined.

Cereulide: What You Need to Know
It's a toxin, not a bacterium
DetailsCereulide is produced by Bacillus cereus bacteria, but the toxin itself is what causes illness. It's a cyclic depsipeptide — a small, extremely stable molecule.
It cannot be destroyed by cooking
DetailsUnlike most food safety threats, cereulide is heat-stable. Boiling, microwaving, or any preparation method will not neutralize it. Once it's in the formula powder, it stays.
Symptoms are mainly gastrointestinal
DetailsNausea and vomiting are the most common symptoms, typically beginning rapidly after ingestion. Infants under 6 months are more vulnerable because they are more sensitive to dehydration.
It entered through an ingredient supplier
DetailsThe contamination was traced to arachidonic acid (ARA) oil from a Chinese supplier (Cabio Biotech). ARA is added to formula for brain and eye development. Lab analysis showed contamination dates back to at least October 2024.
There was no safety limit before this crisis
DetailsPrior to February 2, 2026, no generally accepted regulatory limit for cereulide in infant formula existed. The EFSA has now proposed a threshold of 0.014 μg/kg bodyweight.
Cereulide contamination in infant formula at this scale is unprecedented. The regulatory framework is being built in real time.

What About European Formula Imports?

A significant number of US parents import European formula — brands like HiPP, Holle, Aptamil, and others — through third-party retailers and online sellers. The 2026 cereulide crisis is directly relevant to these families.

If You Import European Formula

  • The cereulide crisis affected brands not sold in US stores — Aptamil, SMA, Cow & Gate, NAN, BEBA, and others are primarily European and international brands
  • If you import any of these brands into the US, you are operating outside the FDA recall system — the FDA cannot recall products it does not regulate
  • The RASFF portal (webgate.ec.europa.eu/rasff-window/portal) is the European equivalent of the FDA recall database — bookmark it if you use imported formula
  • Some US parents buy European formula from third-party importers or online retailers. These sellers may not proactively notify you about recalls. You are responsible for monitoring safety alerts yourself.
  • The ARA oil contamination affected multiple suppliers and production facilities. Even brands that initially seemed unaffected expanded their recalls as more testing was completed.
  • Kendamil is both sold in the US and affected by the cereulide crisis (in Canada). Check the specific lot numbers if you use Kendamil.

The cereulide crisis has underscored a real risk of using formula outside your country's regulatory system: when a recall happens, the safety net you're relying on is not designed to catch you.

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Log the formula brand and lot number with each feed. If a recall ever happens, you'll know immediately whether your baby consumed the affected product — no guessing, no panic-scrolling through receipts.

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What US Parents Should Do Right Now

You do not need to be afraid of the formula on your shelf. But you do need to be informed. Here is the short list.

Action Items for US Parents (February 2026)

  • If you have any ByHeart formula at home — any lot, any product — do not use it. The entire brand's production history is recalled.
  • Check the FDA recall database at FDA.gov/safety/recalls-market-withdrawals-safety-alerts for the most current information on all active recalls
  • If your baby consumed ByHeart formula and is showing symptoms (constipation, poor feeding, loss of head control, difficulty swallowing, lethargy), contact your pediatrician immediately — symptoms can appear weeks after ingestion
  • If you import European formula (HiPP, Holle, Aptamil, SMA, or others), check the manufacturer's website and the RASFF portal for your specific product and lot number — the cereulide recalls affect 60+ countries
  • Kendamil sold in the US has not been recalled by the FDA. The Canadian recall affects specific lots sold at Costco Canada only. If you buy Kendamil in the US through authorized retailers, your product is not currently affected.
  • Log your formula brand and lot number with every new container. If a recall happens, you'll know immediately whether your baby consumed the affected product.
  • Sign up for FDA email alerts at FDA.gov so you hear about recalls the day they are announced — not from social media three days later

The US formula supply in stores is safe. These actions are about staying informed and having a system — not about living in fear.

Putting 2026 in Context

  • The ByHeart botulism outbreak (2025–2026) was the first known infant botulism event linked to formula anywhere in the world — it is genuinely unprecedented
  • The global cereulide crisis is one of the largest infant formula safety events in history by geographic scope — 60+ countries affected across multiple manufacturers
  • Both events trace back to ingredient suppliers, not the formula manufacturers' own facilities — a pattern that is reshaping how the industry manages supply chain risk
  • The FDA has begun implementing new procedures for congressional notification of formula recalls and is strengthening its recall enforcement capabilities
  • Despite these headline events, millions of formula feedings continue to happen safely every single day in the United States
  • US FDA-regulated formulas (Similac, Enfamil, Gerber, Bobbie, Kirkland, store brands) have not been affected by the 2026 cereulide contamination
  • The EFSA (European Food Safety Authority) set the first-ever safety threshold for cereulide in infant formula on February 2, 2026 — there was no standard before this crisis forced the issue

Two unprecedented events happening at the same time feels alarming. But understanding what each one actually means — and whether it affects your formula — makes a meaningful difference.

When to Talk to Your Pediatrician

  • Your baby has consumed recalled ByHeart formula at any point and is showing any symptoms — constipation, poor feeding, loss of head control, difficulty swallowing, or lethargy
  • Your baby consumed ByHeart formula and seems fine — contact your pediatrician anyway for guidance on monitoring, since botulism symptoms can take weeks to appear
  • You use imported European formula that may be affected by the cereulide recalls and your baby is showing gastrointestinal symptoms — vomiting, nausea, or diarrhea
  • You need to switch formulas due to a recall and want guidance on the best replacement for your baby's specific needs
  • You are anxious about formula safety and it is affecting your ability to feed your baby confidently — your pediatrician can help put the risk in context

When in doubt, call. Your pediatrician would rather hear from you and reassure you than have you worry in silence.

The Bottom Line

2026 has been an unprecedented year for formula safety — and it's only February. The ByHeart botulism recall was the first of its kind in formula history. The global cereulide crisis is one of the largest formula safety events ever by geographic scope. Both trace back to ingredient suppliers, not to the formula manufacturers' own factories — a pattern that is forcing the entire industry to rethink how it manages supply chain risk.

For US parents using FDA-regulated formula from US stores: your supply is not affected by the cereulide crisis. The only active US FDA formula recall is ByHeart, which represented about 1% of the market. There is no formula shortage.

For parents importing European formula: this is a direct and ongoing concern. Check your products, check the lot numbers, and understand that you are responsible for monitoring safety alerts from the relevant European authorities.

Your job as a parent is not to be scared of formula. It is to know where to check, to keep your lot numbers accessible, and to have a system in place so that when a recall is announced, you can verify in five minutes whether it affects your family. That's it. That's the whole thing.

For the full history of every major formula recall in the US, see our complete formula recall history. For a brand-by-brand breakdown of recall records, see our formula recall safety scorecard. For step-by-step instructions on checking recalls, see our how to check for recalls guide.

Related Guides

Sources

  • U.S. Food and Drug Administration. (2026). FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula. FDA.gov.
  • U.S. Food and Drug Administration. (2025). Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). FDA.gov.
  • U.S. Food and Drug Administration. (2025). FDA's Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula. FDA.gov.
  • U.S. Food and Drug Administration. (2026). FDA Recall Database — Safety Reporting Portal. FDA.gov/safety/recalls-market-withdrawals-safety-alerts.
  • Centers for Disease Control and Prevention. (2026). Investigation Update: Infant Botulism Outbreak, January 23, 2026. CDC.gov.
  • European Food Safety Authority. (2026). EFSA Reviews Cereulide Infant Formula Incident. EFSA.europa.eu.
  • European Food Safety Authority. (2026). EFSA Sets Safety Thresholds for Cereulide Toxin in Infant Formula. EFSA.europa.eu.
  • Canadian Food Inspection Agency. (2026). Kendamil Brand Infant Formula With Whole Milk Recalled Due to Cereulide Toxin. recalls-rappels.canada.ca.
  • Nestlé Global. (2026). Infant Formula Product Advisory. Nestle.com.
  • Danone. (2026). Aptamil and Cow & Gate Product Recall Information. Danone.com.
  • CNBC. (2026). French Prosecutors Are Investigating Companies Like Nestle and Danone Over Contaminated Baby Formula. cnbc.com.
  • Food Safety News. (2026). Nestlé Expands Infant Formula Recall. foodsafetynews.com.
  • Food Safety News. (2026). Infant Formula Contamination Dates Back to 2024. foodsafetynews.com.
  • ByHeart Inc. (2025). Voluntary Recall — November 2025. ByHeart.com.
  • U.S. Department of Health and Human Services, Office of Inspector General. (2024). The FDA's Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply. oig.hhs.gov.

Medical Disclaimer

This guide is for informational purposes only and is not a substitute for professional medical advice. Recall data is based on publicly available FDA, CDC, EFSA, CFIA, and manufacturer records as of February 26, 2026 and may not reflect the most current information. Always check the FDA recall database and relevant international food safety authorities directly for current recalls. If you have concerns about your baby's formula or health, please consult your pediatrician.

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