GUIDE
Formula recalls are rare, the safety system works, and millions of feedings happen safely every day.
A clear-eyed look at every major formula recall in US history — what happened, why, and what it means for your family. Facts, not fear.
Formula recalls are frightening for parents. The idea that something you are feeding your baby every day might be unsafe triggers a visceral, protective response. That reaction is completely normal and completely understandable.
But it is important to put recalls in context. The US infant formula supply is one of the most heavily regulated food products in the country. The FDA sets strict nutritional and manufacturing standards under the Infant Formula Act of 1980 and subsequent regulations. Manufacturers are required to test finished products, maintain quality systems, and report potential issues to the FDA.
When a recall does happen, it means the system is working. Contamination was detected, authorities were notified, and the product was pulled. That is the safety net functioning exactly as designed. The goal of this guide is to give you a factual, chronological understanding of what has happened — not to amplify fear, but to give you the information you need to stay informed and make calm decisions.
The following table documents the most significant formula recalls in US history. This is not an exhaustive list of every labeling recall or minor Class III event — it focuses on recalls that had meaningful safety implications or public impact.
| Year | Brand / Product | FDA Class | Reason | Scope | Outcome |
|---|---|---|---|---|---|
| 2025 | ByHeart | Class I | Clostridium botulinum contamination — first known infant botulism outbreak linked to infant formula worldwide | All ByHeart Whole Nutrition Infant Formula ever produced — cans and single-serve packs | 51 infants hospitalized across 19 states (as of Dec 2025). No deaths reported. Botulinum confirmed in finished product and organic whole milk powder ingredient. FDA issued warning letters to Walmart, Target, and other retailers for failing to remove recalled product from shelves. |
| 2024 | Dairy Manufacturers Inc. (Crecelac, Farmalac) | Regulatory | Products not evaluated by FDA — non-compliant with infant formula registration requirements (21 CFR 106.110) | All US-distributed lots of Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose | No reported illnesses. Products recalled and FDA terminated the recall after completion. |
| 2024 | Mt. Capra (Goat Milk Formula Recipe Kit) | Regulatory | FDA determined the formula recipe kit does not meet all FDA requirements for infant formula and does not provide sufficient nutrition | 1,506 boxes recalled | No reported illnesses. Regulatory non-compliance recall. |
| 2023 | Reckitt / Mead Johnson (Nutramigen) | Class II | Cronobacter sakazakii contamination confirmed by Israeli Ministry of Health in product from Zeeland, MI facility | 675,000+ cans of Nutramigen 12.6 oz and 19.8 oz powder | No reported illnesses. Most product likely already consumed by time of recall. FDA had previously issued warning letter to Mead Johnson in Aug 2023 for Cronobacter detections in manufacturing zones. |
| 2023 | Perrigo (Gerber Good Start SoothePro) | Class II | Potential Cronobacter sakazakii contamination at Eau Claire, WI facility | Multiple lots of 12.4 oz, 19.4 oz, and 30.6 oz containers. Recall extended in May 2023 after recalled product was distributed to retailers post-recall. | No distributed product tested positive. No reported illnesses. FDA issued warning letter to Perrigo in Aug 2023. |
| 2023 | Reckitt / Mead Johnson (Enfamil ProSobee) | Class II | Possible Cronobacter sakazakii cross-contamination from third-party material supplier | ~145,000 cans of ProSobee 12.9 oz Simply Plant-Based formula (US, Guam, Puerto Rico) | All product tested negative. No reported illnesses. Root cause traced to third-party supplier material; supplier relationship terminated. |
| 2022 | ByHeart | Class II | Possible Cronobacter sakazakii cross-contamination — positive test at third-party packaging facility | 5 batches of ByHeart Whole Nutrition Infant Formula (24 oz containers) | No reported illnesses. FDA inspected ByHeart's manufacturing facility Dec 2022–Feb 2023. FDA issued warning letter in Aug 2023 for manufacturing deficiencies. |
| 2022 | Abbott (Similac, Alimentum, EleCare) | Class I | Cronobacter sakazakii and Salmonella Newport contamination at Sturgis, MI facility | Nationwide — all powdered formula produced at Sturgis plant | 4 infant illnesses, 2 deaths, plant shutdown for ~5 months, nationwide formula shortage. Abbott now operates under FDA consent decree. |
| 2022 | Abbott (Similac and other liquid products) | Class II | Cap seal defect on 2 fl oz Ready-to-Feed liquid bottles — potential spoilage | Multiple lots from Columbus, OH facility. Distributed primarily to hospitals, doctors' offices, and some retailers. | No confirmed serious illnesses. Less than 1% of bottles affected. |
| 2024 | Perrigo (H-E-B, CVS store brands) | Class II | Vitamin D levels above maximum level permitted in store-brand Premium Infant Formula with Iron | 16,500 cans across 3 lots. Sold at H-E-B in TX and CVS in 12 states. | No reported illnesses. |
| 2024 | Sammy's Milk (Goat Milk Toddler Formula) | Regulatory | FDA concerned product was marketed for infants despite toddler labeling — did not meet infant formula requirements | All product distributed Feb–Apr 2024. Online sales only. | FDA warning letter Aug 2024. No reported illnesses. |
| 2019 | Perrigo (Parent's Choice Advantage) | Class II | Potential presence of metal foreign matter in powdered infant formula | 23,388 containers of 35 oz Parent's Choice Advantage at Walmart | No reported illnesses. Recall completed and terminated. |
| 2016 | Sammy's Milk | Class II | Possible Cronobacter sakazakii contamination in Sammy's Milk Baby Food | All lots of Sammy's Milk Baby Food | Precautionary recall. |
| 2010 | Abbott (Similac) | Class I | Insect contamination — small beetles and larvae found in powdered formula | Approximately 5 million containers recalled | No confirmed illnesses. Contamination traced to a single manufacturing facility. |
| 2007 | Hain Celestial (Earth's Best Organic) | Class I | Potential Clostridium botulinum contamination in Earth's Best Organic Stage 2 baby food | Two product lines of baby food (not infant formula) | Precautionary recall. No confirmed illnesses. |
| 2006 | Mead Johnson (Enfamil) | Class II | Possible Cronobacter contamination in powdered formula | Limited batch recall | Precautionary recall. Investigation found no confirmed illnesses linked to the product. |
| 2003 | Mead Johnson (EnfaCare Lipil) | Class I | Enterobacter sakazakii contamination in powdered formula for preterm infants | 505 cases (3,030 cans) of 12.9 oz formula distributed to hospitals, retail stores, and WIC clinics nationwide | Class I recall. No confirmed illnesses reported from distributed product. |
| 2002 | Wyeth (now Pfizer) | Class I | Cronobacter sakazakii contamination in powdered formula | Single lot recall in Tennessee | One infant death attributed to Cronobacter infection. Led to increased FDA scrutiny of powdered formula manufacturing. |
| 2001 | Mead Johnson (Portagen) | Class I | Enterobacter sakazakii contamination in specialty formula for infants with fat digestion difficulties | 17,358 cans recalled | One premature infant death from meningitis caused by Enterobacter sakazakii. Class I recall. |
| 2001 | Mead Johnson (Enfamil) | Class II | Labeling error — wrong product in containers | Limited regional recall | No confirmed illnesses. Containers of one formula type were labeled as another. |
| 2000 | Nestle (Carnation Good Start, Alsoy, Follow-Up) | Class II | Processing may not have reached temperatures high enough to ensure sterility | Approximately 2.5 million cans of 13 oz concentrate | No confirmed illnesses. |
| 1979 | Syntex (Neo-Mull-Soy) | N/A (Pre-modern system) | Chloride deficiency in soy formula formulation | Nationwide | Approximately 20,000-50,000 infants affected with metabolic alkalosis. Led directly to the Infant Formula Act of 1980, which gave the FDA authority to set nutritional standards for formula. |
The 2025 ByHeart recall is historically significant — it represents the first known outbreak of infant botulism linked to infant formula anywhere in the world since infant botulism was first described as a clinical entity almost 50 years ago.
ByHeart launched in 2022 as a premium, direct-to-consumer infant formula brand. Within months, the company recalled 5 batches for potential Cronobacter cross-contamination (December 2022). The FDA inspected ByHeart's manufacturing facility from December 2022 through February 2023 and issued a warning letter in August 2023 for failing to ensure products were not contaminated with microorganisms.
In November 2025, the FDA became aware of a cluster of infant botulism cases linked to ByHeart formula. On November 7, the FDA recommended a voluntary recall. On November 8, the FDA issued a public warning. By November 11, the recall was expanded to include all lots of infant formula ever produced by ByHeart.
As of December 2025, the CDC identified 51 infants across 19 states with suspected or confirmed infant botulism who had consumed ByHeart formula. All 51 required hospitalization. No deaths were reported. When investigators examined earlier cases, they found 10 additional infants who had consumed ByHeart and fell ill between December 2023 and July 2025.
Testing confirmed Clostridium botulinum in 6 of 36 finished product samples, and genetic sequencing matched the contamination to organic whole milk powder — an ingredient used in ByHeart's manufacturing process. ByHeart stated it could not rule out that all formula across all product lots may have been contaminated.
The FDA conducted over 4,300 retail checks and found recalled ByHeart formula still on shelves — in some cases for over three weeks after the recall, across 175 locations in 36 states. The FDA issued warning letters to Walmart, Target, and other retailers. In one case, recalled formula was found with promotional sale signage.
ByHeart formula represented approximately 1% of US formula sales, so the recall did not create a supply shortage.
2023 was a significant year for formula safety. Three manufacturers — Reckitt (Mead Johnson), Perrigo, and ByHeart — all initiated recalls for Cronobacter sakazakii contamination concerns within months of each other. All three subsequently received FDA warning letters in August 2023.
In February 2023, Reckitt recalled approximately 145,000 cans of Enfamil ProSobee Simply Plant-Based formula for potential Cronobacter cross-contamination traced to a third-party material supplier. All distributed product tested negative and no illnesses were reported.
In March 2023, Perrigo recalled multiple lots of Gerber Good Start SoothePro powdered formula manufactured at its Eau Claire, Wisconsin facility for potential Cronobacter contamination. No distributed product tested positive. The recall was extended in May 2023 after Associated Wholesale Grocers distributed recalled product to Nashville-area retailers post-recall.
In December 2023, Reckitt recalled over 675,000 cans of Nutramigen powder after the Israeli Ministry of Health confirmed Cronobacter sakazakii in product imported from Mead Johnson's Zeeland, Michigan facility. The FDA's August 2023 warning letter had already cited Cronobacter detections in high and critical hygiene zones at the same facility.
These events, combined with the 2022 Abbott and ByHeart recalls, led to increased FDA scrutiny of infant formula manufacturing and the hiring of dedicated critical foods officers within the agency.
The 2022 Abbott recall was the most significant infant formula safety event in modern US history, and it deserves a detailed account.
In September 2021, the FDA received a complaint about a Cronobacter sakazakii infection in an infant who had consumed powdered Similac formula. Over the following months, additional reports emerged. In February 2022, Abbott Nutrition voluntarily recalled powdered formulas produced at its Sturgis, Michigan facility — including Similac, Alimentum, and EleCare.
Four infant illnesses were linked to Cronobacter or Salmonella in infants who had consumed formula from the Sturgis plant. Two of those infants died. It is important to note that the FDA investigation found Cronobacter in the plant environment but was unable to definitively match the plant strains to the strains in all of the infected infants. The causal link remains established for some cases and debated for others.
The Sturgis plant — which produced roughly 40% of the US powdered formula supply — was shut down from February through July 2022. This single plant closure, combined with existing supply chain issues, triggered a nationwide formula shortage that left parents scrambling to find food for their babies. The shortage was worst in May and June 2022, when out-of-stock rates exceeded 70% in some regions.
The fallout was significant. The FDA was criticized for its slow initial response to the September 2021 complaint. New legislation — the FORMULA Act — was passed to strengthen FDA oversight and create emergency import authorities. The incident exposed how concentrated and fragile the US formula supply chain was.
Before 2022, the most consequential formula safety event in US history occurred in 1979. Syntex Laboratories produced a soy-based formula called Neo-Mull-Soy that was deficient in chloride — an essential electrolyte. An estimated 20,000 to 50,000 infants who consumed the formula developed metabolic alkalosis, and some experienced long-term developmental effects.
This crisis directly led to the passage of the Infant Formula Act of 1980, which gave the FDA authority to set specific nutritional standards for infant formula and required manufacturers to test finished products. Before this law, formula manufacturing had less regulatory oversight. Every nutritional standard and testing requirement that exists today traces back to this event.
The 1979 crisis is a reminder that regulation matters — and that the safety system that protects babies today exists because of past failures that were taken seriously.
Understanding how recalls work reduces anxiety. When you know the system, you know what to watch for and what to do.
| Step | What Happens |
|---|---|
| 1. Detection | Contamination or defect is identified through internal quality testing, consumer complaints, or FDA inspection. Manufacturers are required to report to the FDA. |
| 2. Investigation | The FDA and manufacturer investigate the scope — which lots, which facilities, which distribution channels are affected. |
| 3. Classification | The FDA classifies the recall as Class I, II, or III based on the probability and severity of potential health consequences. |
| 4. Public Notification | For Class I and II recalls, the FDA issues a public alert. Retailers are notified to pull affected products from shelves. |
| 5. Consumer Action | Parents check lot numbers, stop using affected product, and contact the manufacturer for refunds or replacements. |
| 6. Resolution | The manufacturer corrects the issue, the FDA verifies the correction, and production may resume once safety standards are met. |
| Classification | Severity | What It Means | Examples | How Common |
|---|---|---|---|---|
| Class I | Most Serious | Reasonable probability that use of the product will cause serious adverse health consequences or death. | Microbial contamination (Cronobacter, Salmonella), dangerous foreign objects, grossly incorrect formulation | Rare — these trigger immediate public alerts and widespread media coverage |
| Class II | Moderate | Product may cause temporary or medically reversible adverse health consequences. Probability of serious harm is remote. | Minor contamination, labeling errors (wrong allergen info), cross-contamination with trace amounts of another product | Occasional — most formula recalls fall into this category |
| Class III | Lowest | Product is not likely to cause adverse health consequences. | Labeling errors that don't affect safety (wrong weight listed, missing barcode), cosmetic packaging issues | Most common across all food recalls. Rarely makes the news. |
Every food product category experiences recalls — peanut butter, lettuce, chicken, cereal, baby food pouches. Formula is actually recalled less frequently than many other infant and toddler food products. The emotional weight of formula recalls is higher because babies are the sole consumers, but the actual frequency is low.
This is important to understand: powdered infant formula is not a sterile product. The FDA acknowledges this directly. That is why preparation guidelines recommend using water that is at least 158 degrees F (70 degrees C) when preparing formula for high-risk infants (premature, immunocompromised). For healthy full-term babies, room temperature or warm water is standard practice, but knowing the baseline matters.
Larger manufacturers produce more formula in more facilities with more product lines. Statistically, they have more opportunities for something to go wrong — and more recalls in their history. This does not necessarily mean their products are less safe. Smaller brands have less history, which means less data, not necessarily better safety. For a brand-by-brand breakdown, see our formula recall scorecard.
Ready-to-feed (liquid) formula is commercially sterile — it has been heat-treated to kill bacteria. It is the recommended format for premature infants and hospitalized babies. It is also more expensive and produces more waste. For healthy full-term babies, powdered formula prepared according to instructions is safe for daily use.
Log the formula brand 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.
You do not need to live in fear of recalls. But having a simple system to check when one is announced takes 5 minutes to set up and gives you genuine peace of mind.
The lot number is printed on the bottom or side of every formula container. Write it down, photograph it, or log it when you open a new can. If a recall is announced, the lot number is how you determine whether your specific container is affected.
The FDA maintains a searchable database of all recalls at FDA.gov/safety/recalls-market-withdrawals-safety-alerts. Bookmark it. It is the authoritative source — not social media, not parent forums, not news headlines.
You can subscribe to email notifications from the FDA for food and formula recalls. Go to FDA.gov and look for the 'Subscribe to Email Updates' option. You will be notified when any infant formula recall is announced.
Abbott, Reckitt (Mead Johnson), Nestle/Gerber, and other manufacturers maintain their own recall pages. These often have lot number lookup tools that let you enter your specific product details.
Facebook groups and parenting forums spread recall information fast — but also spread misinformation. A viral post about a 'formula recall' may be outdated, exaggerated, or completely fabricated. Always verify with the FDA database before taking action.
Recalls are a sign that the safety system is working — contamination is being caught and unsafe products are being removed. The goal is not zero risk (which is impossible in any food supply), but functional oversight that catches and corrects problems quickly.
If your baby has consumed a recalled product and seems fine, contact your pediatrician for guidance anyway. Most exposures do not result in illness, but your doctor can advise on monitoring and next steps.
Formula recalls are serious when they happen, and they are more frequent than many parents assume. The 2022 Abbott recall was a genuinely significant event that exposed supply chain vulnerabilities and led to real regulatory changes. The 2023 wave of Cronobacter recalls across three manufacturers revealed that contamination challenges are an industry-wide concern, not isolated to a single company. The 2025 ByHeart botulism outbreak — the first of its kind in formula history — showed that newer brands are not immune to serious safety events. Earlier recalls shaped the very laws that protect babies today.
Your job as a parent is not to live in fear of recalls. It is to know where to check, to keep your lot numbers accessible, and to follow your pediatrician's guidance if a recall does affect your formula. The system is not perfect — no food safety system is — but it is functional, it is improving, and millions of formula feedings happen safely every single day.
For a brand-by-brand breakdown of recall histories, see our formula recall safety scorecard.
This guide is for informational purposes only and is not a substitute for professional medical advice. If you believe your baby has consumed a recalled product or is showing signs of illness, contact your pediatrician immediately.
