The Short Answer
Check your pantry immediately if you use ByHeart, Nutramigen, or Crecelac. The FDA and CDC closely monitor infant formula, but recalls still happen frequently due to dangerous bacterial contamination.
The most recent major incident was a nationwide recall of all ByHeart formula in November 2025. Over 15 infants were hospitalized with infant botulism, leading to the largest recall since the massive 2022 Abbott shortage.
Why This Matters
Infants under six months old are highly vulnerable to bacterial infections. Their immune systems and digestive tracts are still developing, making contaminants like Cronobacter and botulism spores potentially fatal. Heavy Metals Baby Formula
Recalled formulas often stay on store shelves weeks after an announcement. During the 2025 ByHeart recall, FDA regulators continued to find contaminated batches at major retailers like Target and Walmart days later, meaning you cannot rely on the store to pull the product. Is Formula Fda Regulated
Powdered infant formula is not sterile. Unlike liquid, ready-to-feed formulas, powders can harbor bacteria from the manufacturing facility or from your own kitchen if prepared improperly. Boil Water Formula
What's Actually Causing Formula Recalls
- Clostridium botulinum (ByHeart) — This bacteria causes infant botulism, a severe neurological condition. ByHeart recalled all formula batches in November 2025 after 15 infants across 10 states were hospitalized. Is Byheart Good
- Cronobacter sakazakii (Nutramigen) — This environmental germ causes life-threatening meningitis in newborns. Reckitt recalled 675,030 cans of Nutramigen in January 2024 after the bacteria was detected in exported batches. Similac Vs Enfamil
- Cronobacter sakazakii (Crecelac) — In July 2024, the FDA found Cronobacter in Crecelac Goat Milk formula that had already been recalled for bypassing premarket notifications. Goat Vs Cow Milk Formula
- Cronobacter sakazakii (Similac) — This is the exact pathogen that sparked the nationwide formula shortage in February 2022 when Abbott recalled Similac, Alimentum, and EleCare. Similac Vs Enfamil Comparison
What to Look For
Green Flags:
- Ready-to-feed liquids — These formulas are commercially sterile and pose a significantly lower risk of bacterial infection for newborns under three months old.
- Rigorous European standards — Brands manufactured in Europe often undergo stricter batch testing before hitting shelves, reducing the risk of wide-scale contamination. European Vs American Formula
Red Flags:
- Dented or damaged cans — Micro-cracks can break the factory seal, allowing bacteria to enter the sterile powder during shipping.
- Unverified importers — Third-party sellers bypass FDA screening, meaning you won't get notified if the European formula you bought online gets recalled. Why European Formula Expensive
The Best Options
While no brand is immune to a recall, some have cleaner recent track records and tighter manufacturing processes. Safest Formula Brands
| Brand | Product | Verdict | Why |
|---|---|---|---|
| Kendamil | Kendamil Classic | ✅ | Zero recent FDA recalls and rigorous European quality control. |
| Abbott | Similac 360 Total Care | ⚠️ | Recalled in 2022, but now operates under the strictest FDA oversight. |
| ByHeart | Whole Nutrition Formula | 🚫 | Suffered a massive nationwide recall in Nov 2025 due to botulism. |
The Bottom Line
1. Check your lot numbers. — Always cross-reference the bottom of your can with the FDA's active recall list before opening a new container.
2. Consider ready-to-feed. — Liquid formula is sterile and is the safest option for premature babies or infants under three months.
3. Use safe prep methods. — Boiling your water to 158°F (70°C) before mixing powder kills Cronobacter and keeps your baby safe. Tap Water Formula
FAQ
What is Cronobacter sakazakii?
It is a naturally occurring germ that can live in dry foods like powdered baby formula. It causes severe, life-threatening blood infections and meningitis in infants under two months old. Preservatives Baby Formula
What are the symptoms of infant botulism?
Symptoms can take weeks to appear and include constipation, weak crying, and poor feeding. It eventually causes progressive muscle paralysis and breathing difficulty, requiring immediate hospitalization. Best Formula Constipation
Can I get a refund for recalled formula?
Yes, manufacturers provide full refunds or replacements for affected lot numbers. Never throw away a recalled can before taking a photo of the batch code on the bottom to submit for your refund. Is Generic Formula Okay
References (9)
- 1. organiclifestart.com
- 2. fda.gov
- 3. drugwatch.com
- 4. cbsnews.com
- 5. aap.org
- 6. time.com
- 7. healthbeat.org
- 8. phillyvoice.com
- 9. fda.gov