GUIDE
Not all formula brands have the same recall history. Here's every major brand rated — transparently, with methodology explained.
We reviewed FDA recall data, enforcement reports, and publicly available safety records for every major formula brand in the US market. Here's what we found.
This scorecard rates every major baby formula brand sold in the US based on publicly available FDA recall data. It is designed to give you a factual, transparent summary of each brand's recall history — not to tell you which formula to buy.
Before you scroll to the table, here are the things you need to understand:
A brand's past recall history tells you what has happened, not what will happen. A brand with a clean record today could have a recall tomorrow. A brand with a significant recall history has also successfully fed millions of babies without incident. Use this as one data point, not the only data point.
Abbott produces roughly 40% of the US formula supply. Perrigo produces the majority of store-brand formula. These companies have enormous production volumes across multiple facilities and product lines. More production means more opportunities for something to go wrong — and more opportunities for something to be caught. A small, new brand with a clean record has simply had fewer chances to be tested.
Where specific recall numbers or dates were not available in the public FDA database, we state that clearly. We use language like 'no publicly available FDA recall data found' or 'limited data available' rather than assigning a number we cannot verify.
Last updated: February 2026. Always verify current recall status at the FDA recall database.
Our recall score considers four factors. Here is exactly how we weighted them — no black box.
| Factor | What We Looked At | How It's Scored |
|---|---|---|
| Total Number of Recalls | How many times the FDA has issued a recall for this brand's products | More recalls = more history. But volume matters — a brand producing 40% of the market will naturally have more events than a brand producing 2%. |
| Recency | When the most recent significant recall occurred | More recent recalls are weighted more heavily. A recall in 2022 is more relevant than one in 2006. |
| Severity (Classification) | The FDA classification of the most serious recall | Class I (potential for serious harm or death) is weighted most heavily. Class III (unlikely to cause harm) is weighted least. |
| Scope and Root Cause | Whether the issue was a manufacturing deficiency, contamination, or labeling error | Manufacturing contamination (Cronobacter, Salmonella) is more concerning than a labeling error. Systemic facility issues are weighted more than isolated batch problems. |
| Score | Indicator | What It Means | Brands |
|---|---|---|---|
| Significant History | Red | Multiple recalls including at least one Class I event with confirmed health consequences. Documented manufacturing or contamination issues. | Similac (Abbott), EleCare (Abbott), ByHeart, Enfamil (Mead Johnson / Reckitt) |
| Notable History | Orange | Multiple recalls documented, including contamination-related events (Class II or above). May include FDA warning letters for manufacturing deficiencies. | Nutramigen (Mead Johnson / Reckitt), Gerber Good Start (Perrigo), Kirkland, Parent's Choice, Up & Up, Burt's Bees Baby |
| Minor History | Yellow | Limited recall history — minor events, non-US regulatory actions, or parent company recall history that does not involve the formula product directly. | Earth's Best, Kendamil |
| Clean Record | Green | No publicly available FDA recall data found. Note: may reflect newer brand with limited production history rather than proven long-term safety. | Happy Baby, Bobbie |
| Regulatory Action | Red-Outline | Product recalled for not meeting FDA infant formula requirements — non-compliance with registration, nutritional standards, or safety evaluations. Not sold through mainstream retail channels. | Crecelac / Farmalac (Dairy Manufacturers Inc.), Mt. Capra, Sammy's Milk |
| EU-Regulated (Not FDA) | Gray | Not FDA-regulated. Falls under European RASFF system. Not legally sold in the US. Recall data is tracked separately and is not directly comparable. | HiPP, Holle |
Here is every major formula brand rated. Read the caveats below the table — they matter.
| Brand | Total FDA Recalls (All Time) | Most Recent Recall | Most Serious Recall Class | Reason(s) | Recall Score |
|---|---|---|---|---|---|
| Similac (Abbott) | Multiple recalls documented | 2022 | Class I | Cronobacter sakazakii contamination at Sturgis facility (Feb 2022, Class I — 4 illnesses, 2 deaths), cap seal defect on 2 fl oz liquid products from Columbus facility (Oct 2022), insect contamination (2010, Class I — ~5 million containers), various labeling recalls | Significant History |
| EleCare (Abbott) | Included in Abbott recalls | 2022 | Class I | Included in the 2022 Sturgis facility recall (Cronobacter). Same manufacturing facility as Similac. | Significant History |
| ByHeart | Multiple recalls — including major Class I event | 2025 | Class I | Clostridium botulinum contamination (Nov 2025, Class I — 51 infants hospitalized across 19 states, all product ever produced recalled). Cronobacter sakazakii cross-contamination (Dec 2022 — 5 batches). FDA warning letter issued Aug 2023 for manufacturing deficiencies. | Significant History |
| Enfamil (Mead Johnson / Reckitt) | Multiple recalls documented, including Class I events | 2023 | Class I | Nutramigen recall for Cronobacter contamination (Dec 2023 — 675,000+ cans). ProSobee recall for Cronobacter cross-contamination (Feb 2023 — 145,000 cans). EnfaCare Lipil recall for Enterobacter sakazakii contamination (2003, Class I). Portagen recall for Enterobacter sakazakii — 1 premature infant death (2001, Class I). Possible Cronobacter contamination (2006). FDA warning letter issued Aug 2023. | Significant History |
| Nutramigen (Mead Johnson / Reckitt) | Standalone recall documented | 2023 | Class II | Recalled Dec 2023 for Cronobacter sakazakii contamination confirmed by Israeli health authorities — 675,000+ cans of hypoallergenic powder formula from Zeeland, MI facility. Same facility cited in Aug 2023 FDA warning letter for Cronobacter detections in manufacturing zones. | Notable History |
| Gerber Good Start (Perrigo) | Recall documented for Cronobacter contamination | 2023 | Class II | Gerber Good Start SoothePro recall for potential Cronobacter sakazakii contamination (Mar 2023, manufactured by Perrigo at Eau Claire, WI facility — multiple lots across 12.4 oz, 19.4 oz, and 30.6 oz sizes). Recall extended in May 2023 after recalled product was distributed to retailers post-recall. Perrigo received FDA warning letter Aug 2023. | Notable History |
| Earth's Best (Hain Celestial) | Limited recall history | 2007 (baby food, not formula-specific) | Class I (baby food) | Hain Celestial recalled Earth's Best Organic Stage 2 baby food products in Feb 2007 for potential Clostridium botulinum contamination. No formula-specific recalls found. Heavy metals lawsuits pending (not FDA recalls). | Minor History |
| Happy Baby (Nurture Inc. / Danone) | No publicly available FDA recall data found | N/A | N/A | No formula-specific recalls found. Heavy metals lawsuits pending for baby food products (not FDA recalls). Formula line no longer sold in US. | Clean Record |
| Bobbie | Pre-launch regulatory issue (2019); no recalls since relaunch | 2019 (regulatory, pre-relaunch) | Regulatory (labeling) | In 2019, during a pilot phase, FDA found labeling non-compliance. Bobbie spent 14 months working with FDA and relaunched January 2021 as fully FDA-registered. No recalls or safety events since relaunch. | Clean Record |
| Kendamil | No US FDA recalls; Canadian recall in 2026 | 2026 (Canada — CFIA, not FDA) | N/A (US) | No US FDA recalls found. In Feb 2026, Canadian Food Inspection Agency (CFIA) recalled Kendamil Whole Milk Infant Formula sold at Costco Canada for potential cereulide toxin. UK-based brand that recently entered the US market. | Minor History |
| Kirkland Signature (Perrigo) | Perrigo has had multiple recalls across its product lines | 2024 (Perrigo manufacturer-level) | Class II | Perrigo recalled Gerber Good Start SoothePro for Cronobacter (Mar 2023). Perrigo recalled store-brand formula for elevated Vitamin D (Aug 2024, Class II — H-E-B and CVS brands). Parent's Choice recalled for metal foreign matter (~2019). FDA warning letter to Perrigo Aug 2023. No Kirkland-specific Class I events. | Notable History |
| Parent's Choice (Walmart / Perrigo) | Brand-specific and manufacturer-level recalls | 2023 (Perrigo manufacturer-level) | Class II | Parent's Choice Advantage recalled for potential metal foreign matter (~2019, 23,388 containers at Walmart). Perrigo recalled Gerber Good Start SoothePro for Cronobacter in Mar 2023. Perrigo also recalled store-brand formula for elevated Vitamin D (Aug 2024, Class II — H-E-B and CVS brands). FDA warning letter to Perrigo Aug 2023. | Notable History |
| Up & Up (Target / Perrigo) | Same manufacturer as Kirkland and Parent's Choice (Perrigo) | 2023 (Perrigo manufacturer-level) | Class II | Same manufacturer and recall profile as other Perrigo-produced store brands. Perrigo received FDA warning letter in Aug 2023. | Notable History |
| Burt's Bees Baby (Perrigo) | Same manufacturer as store brands (Perrigo) | 2023 (Perrigo manufacturer-level) | Class II | Manufactured by Perrigo. Same recall profile as other Perrigo-produced formulas. Perrigo received FDA warning letter in Aug 2023. | Notable History |
| Crecelac / Farmalac (Dairy Manufacturers Inc.) | Recalled for FDA non-compliance | 2024 | Regulatory (non-compliance) | Voluntarily recalled May 2024 — products had not been evaluated by FDA to determine whether they meet US food safety and nutritional standards. Non-compliant with 21 CFR 106.110 new infant formula registration requirements. | Regulatory Action |
| Mt. Capra Goat Milk Formula Recipe Kit | Recalled for FDA non-compliance | 2024 | Regulatory (non-compliance) | Recalled May 2024 — FDA determined the formula recipe kit does not meet all FDA requirements for infant formula and does not provide sufficient nutrition when used as an infant formula. 1,506 boxes recalled. | Regulatory Action |
| Sammy's Milk | Multiple recalls — Cronobacter and regulatory | 2024 | Class II / Regulatory | All lots recalled for possible Cronobacter sakazakii (2016). Goat Milk Toddler Formula recalled Apr 2024 — FDA concerned product was marketed for infants despite toddler labeling and did not meet infant formula requirements. FDA warning letter Aug 2024. Sold online only. | Regulatory Action |
| HiPP | Not FDA-regulated | N/A (US) | N/A (US) | European brand regulated under EU/RASFF system, not FDA. Not legally sold in the US. RASFF alerts have been issued for HiPP products in Europe. | EU-Regulated (Not FDA) |
| Holle | Not FDA-regulated | N/A (US) | N/A (US) | European brand regulated under EU/RASFF system, not FDA. Not legally sold in the US. Some RASFF notifications documented in Europe. | EU-Regulated (Not FDA) |
No scorecard can tell you which formula is 'safest.' It can only tell you what has happened in the past. Use this as context, not as a verdict.
A few things about the formula market that affect how you should read this scorecard:
Abbott (Similac, EleCare, Alimentum) has the most extensive recall history, including the 2022 Class I recall that resulted in a nationwide shortage. Abbott is also the largest infant formula manufacturer in the US, producing roughly 40% of the domestic supply. The 2022 event was a genuine safety failure — Cronobacter contamination at the Sturgis, MI plant caused 4 illnesses and 2 infant deaths. Abbott also recalled 2 fl oz liquid products from its Columbus, OH facility in October 2022 for cap seal defects. Since then, Abbott has invested in facility upgrades and operates under an FDA consent decree. Whether that history affects your purchasing decision is a personal judgment.
ByHeart was a newer brand that launched in 2022 and quickly became a cautionary example. Within months of launching, ByHeart recalled 5 batches for Cronobacter cross-contamination (December 2022). The FDA inspected ByHeart's manufacturing facility and issued a warning letter in August 2023 for failing to ensure products were not contaminated with microorganisms. In November 2025, ByHeart was linked to a multistate infant botulism outbreak — the first known botulism outbreak tied to infant formula anywhere in the world. As of December 2025, 51 infants across 19 states were hospitalized, and all ByHeart formula ever produced was recalled. Clostridium botulinum was confirmed in both finished product samples and an ingredient (organic whole milk powder). The FDA issued warning letters to retailers including Walmart and Target for failing to remove the recalled product from shelves.
Mead Johnson / Reckitt (Enfamil, Nutramigen, ProSobee) has a recall history spanning decades, including two Class I events. In 2001, Mead Johnson recalled Portagen formula after a premature infant died from Enterobacter sakazakii meningitis — a Class I event. In 2003, EnfaCare Lipil was recalled for Enterobacter sakazakii contamination (Class I). More recently, in February 2023, Reckitt recalled 145,000 cans of Enfamil ProSobee for Cronobacter cross-contamination, and in December 2023, over 675,000 cans of Nutramigen were recalled after the Israeli Ministry of Health confirmed Cronobacter in product from Mead Johnson's Zeeland, MI facility. The FDA issued a warning letter to Mead Johnson in August 2023 after inspections found Cronobacter detections in high and critical hygiene zones at the Zeeland plant. Mead Johnson is the second-largest formula manufacturer in the US.
Perrigo (Gerber Good Start, Kirkland, Parent's Choice, Up & Up, Burt's Bees Baby) manufactures the majority of US store-brand formula. Parent's Choice Advantage was recalled for potential metal foreign matter (~2019, 23,388 containers at Walmart). In March 2023, Perrigo recalled Gerber Good Start SoothePro for potential Cronobacter contamination from its Eau Claire, WI facility. The recall was extended in May 2023 after recalled product was found still being distributed to retailers. The FDA issued a warning letter to Perrigo in August 2023. In August 2024, Perrigo recalled store-brand Premium Infant Formula with Iron for elevated Vitamin D levels (Class II — affecting H-E-B and CVS brands). All Perrigo-manufactured store brands share manufacturing facilities and therefore share recall profiles. No Class I events have been linked to Perrigo-manufactured infant formula. Store-brand formula meets the same FDA requirements as name brands.
Bobbie had a regulatory labeling issue in 2019 during its pilot phase, spent 14 months working with the FDA to resolve it, and relaunched in January 2021 as fully FDA-registered. Since its relaunch, Bobbie has had no recalls or safety events. However, the brand has limited production history. A clean record with a few years of data is qualitatively different from a clean record with 20+ years.
Kendamil is a UK-based brand that recently entered the US market. No US FDA recalls have been found. However, in February 2026, the Canadian Food Inspection Agency recalled Kendamil Whole Milk Infant Formula sold at Costco Canada for potential cereulide toxin contamination.
European brands (HiPP, Holle) are not FDA-regulated. They are not legally sold as infant formula in the United States. Parents who import them should understand that these products fall outside the US regulatory system — there is no FDA recall coverage, no US-specific testing requirements, and potential risks from shipping and storage conditions. The EU's RASFF system tracks safety alerts for these brands within Europe.
Log the formula brand and lot number with each feed. If a recall ever happens, you'll know immediately whether your baby was affected — no digging through receipts or trying to remember which can you opened last week.
Knowing the scorecard is useful for context. But what matters most is having a system to check for current recalls in real time.
Look at the bottom or side of your formula container. The lot number is a series of letters and numbers that identifies the specific production batch. Write it down or take a photo.
Go to FDA.gov/safety/recalls-market-withdrawals-safety-alerts. This is the official, authoritative source for all food and formula recalls in the United States.
Use the search function to look for your formula brand. Filter by date if needed. Each recall notice lists the specific lot numbers, product names, and production dates affected.
Match your lot number against the list in the recall notice. If your lot number is listed, follow the instructions in the recall notice — typically stop use immediately and contact the manufacturer for a refund.
Subscribe to FDA email alerts so you are notified proactively when future recalls are announced. This takes 2 minutes and means you will never have to rely on social media or word of mouth for recall information.
HiPP and Holle are popular European formula brands that some US parents import through third-party retailers. These brands are regulated by the European Commission under EU food safety law and monitored by the RASFF (Rapid Alert System for Food and Feed) — not the FDA.
This means:
This does not mean these formulas are unsafe. European food safety standards are rigorous. But if you are using these products in the US, you are operating outside the regulatory system designed to protect you, and you should understand that tradeoff.
The RASFF portal is publicly accessible at webgate.ec.europa.eu/rasff-window/portal. You can search for any European food product, including infant formula, and see safety notifications.
Your pediatrician can help you weigh recall history against other factors — your baby's specific needs, formula availability, and cost — to choose the best option for your family.
Every formula brand has a story. Some have significant recall histories that include real harm to real children. Others have clean records that may simply reflect limited production history. No scorecard can predict the future, and no single data point should drive your formula choice.
What this scorecard can do is give you context. If you are choosing between brands and want to understand their track records, the data is here — transparently scored with methodology explained. Use it alongside other factors: your pediatrician's recommendation, your baby's tolerance, availability, and cost.
The single most important thing you can do for formula safety is not choosing the "right" brand. It is following preparation instructions correctly, storing formula properly, checking the FDA recall database when alerts are issued, and keeping a record of what you are feeding your baby. Those habits protect your baby regardless of which brand is in the can.
For the full history behind these recall scores, see our complete formula recall history. For help understanding what is actually in your formula, see our formula label guide.
This guide is for informational purposes only and is not a substitute for professional medical advice. Recall data is based on publicly available FDA records as of February 2026 and may not reflect the most current information. Always check the FDA recall database directly for current recalls. If you have concerns about your baby's formula or health, please consult your pediatrician.
