URGENT UPDATE: January 31, 2026 – Federal health officials have confirmed the source of a dangerous infant botulism outbreak that has now sickened over 50 babies across 19 states. ByHeart, a direct-to-consumer infant nutrition company, has issued a nationwide recall for all batches of its Whole Nutrition Infant Formula after investigators linked the product to Clostridium botulinum contamination. If you have this formula in your home, stop using it immediately. This breaking development comes as the FDA identifies a specific third-party ingredient supplier responsible for the contamination, marking a significant turn in this ongoing infant health emergency.

ByHeart Formula Recall 2026: Critical Details for Parents

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have escalated their warnings regarding ByHeart products. While the initial safety alert in late 2025 focused on limited batches, the investigation took a dramatic turn this week. As of late January 2026, genetic testing has definitively linked the botulism strain found in sickened infants to organic whole milk powder used in the formula's production.

This "smoking gun" evidence has triggered a total recall of all ByHeart infant formula products, regardless of the expiration date or lot number. This includes:

  • ByHeart Whole Nutrition Infant Formula (24 oz cans)
  • ByHeart "Anywhere Packs" (single-serve sticks)

The contamination has been traced to a third-party supplier, identified in recent reports as Organic West Milk Inc., which provided the organic whole milk powder ingredient. This discovery is crucial because it isolates the issue to a specific supply chain failure rather than a systemic problem with the formula's recipe, though this offers little comfort to parents currently navigating this baby formula safety alert.

FDA Infant Formula Recall List & Batch Numbers

Unlike standard recalls where you check for specific codes, this situation requires a blanket response. Do not check for ByHeart recall batch numbers to see if your can is safe. The company and the FDA have advised that no ByHeart formula currently on the market should be considered safe for consumption. If you possess any of these products, dispose of the powder immediately but keep the can or packaging if you plan to claim a refund.

Infant Botulism Symptoms: What to Watch For

Botulism is a rare but serious illness caused by a toxin that attacks the body's nerves. For infants, whose gut biomes are still developing, ingesting Clostridium botulinum spores can be life-threatening. The current outbreak has resulted in 51 confirmed cases, all of whom required hospitalization. Thankfully, no deaths have been reported as of January 31, 2026.

Parents who have fed their baby ByHeart formula recently should be hyper-vigilant for the following infant botulism symptoms:

  • Constipation: Often the very first sign, lasting several days.
  • Muscle Weakness: A "floppy" appearance, particularly in the neck and head (loss of head control).
  • Weak Cry: A cry that sounds different, softer, or less energetic than usual.
  • Poor Feeding: Difficulty sucking or swallowing, or milk dribbling out of the mouth.
  • Lethargy: Excessive sleepiness or lack of responsiveness.
  • Respiratory Distress: Trouble breathing or shallow breaths.

If you notice any of these signs, seek emergency medical care immediately. Treatment often involves an intravenous antitoxin known as BabyBIG (Botulism Immune Globulin), which can significantly reduce hospital stays and improve recovery times if administered early.

Safe Baby Formula Brands: What Can You Buy Now?

This recall has struck at a chaotic time for the global infant formula market. Adding to the confusion, parents may see headlines about separate recalls for brands like Nestlé and Danone (Aptamil) occurring simultaneously in Europe and the UK due to a different toxin, cereulide. It is vital to distinguish between these events to make safe choices in the US.

For American parents affected by the ByHeart recall, major domestic brands remain unaffected by these specific contamination issues. As of January 2026, the following major brands are not part of the botulism or cereulide recalls in the United States:

  • Enfamil (Reckitt): All lines, including NeuroPro and Enspire, are currently safe and widely available.
  • Similac (Abbott): While facing unrelated legal challenges regarding NEC, Similac products are not subject to this botulism recall and remain a safe, FDA-regulated alternative for immediate nutritional needs.
  • Kendamil: This European-style formula (popular among ByHeart users for its clean ingredient profile) remains unaffected and is available at major US retailers like Target.

If your baby requires a specialized hypoallergenic formula, consult your pediatrician before switching, but know that standard commercial formulas from these major manufacturers are currently secure options.

Next Steps: Refunds and Legal Rights

ByHeart has established a dedicated consumer line for parents to process refunds. You can visit their website to submit a claim form. Given the severity of this infant health emergency news, legal experts anticipate a wave of litigation. If your child was sickened after consuming ByHeart formula, document your medical records and purchase history thoroughly.

This situation is evolving rapidly. We will continue to monitor the FDA infant formula recall list and provide updates as federal investigators release more information about the supply chain breakdown that led to this crisis.