The safety of our little ones is paramount, and when a product designed for infant nutrition is recalled, it raises serious concern and anxiety for parents everywhere.
We are writing to provide essential information regarding the nationwide voluntary recall of ByHeart Whole Nutrition Infant Formula by the manufacturer, ByHeart. This expanded recall includes all batches of their Whole Nutrition Infant Formula cans and Anywhere Pack™ sticks.
The Reason for the Recall
The recall was initiated in close collaboration with the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) following an investigation into a multi-state outbreak of Infant Botulism.
Infant botulism is a rare but serious illness caused by toxins produced by the bacteria Clostridium botulinum in a baby’s immature gut.
- The recall was broadened to all ByHeart products after a number of babies who consumed the formula were identified as part of a larger, ongoing outbreak investigation of infant botulism cases across the U.S.
- While the company states that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin, the decision to recall all products was made out of an abundance of caution to ensure infant safety while the broader investigation continues.
What You Need to Do IMMEDIATELY
If you have any ByHeart Whole Nutrition Infant Formula cans or Anywhere Pack™ sticks in your home, please take the following steps right away:
- Stop Use: Immediately stop feeding your infant any ByHeart formula product.
- Dispose: Discard the product immediately. Do not donate or give it to others.
- Clean: Thoroughly wash any surfaces, feeding bottles, containers, or utensils that may have come into contact with the formula using hot, soapy water or a dishwasher.
- Seek Replacement: Contact ByHeart’s customer service or visit their website for instructions on how to receive a replacement or a refund.
Know the Symptoms of Infant Botulism
Infant botulism can be life-threatening and requires immediate medical attention. Symptoms can take anywhere from a few days up to several weeks to develop.
If your baby has consumed ByHeart formula and exhibits any of the following signs, seek medical care right away:
- Constipation (often the first sign)
- Poor feeding or weak sucking
- Generalized weakness or “floppiness” (loss of head control, low muscle tone)
- Sluggish or decreased facial expression
- Difficulty swallowing
- Weak or altered cry
- Difficulty breathing
Product Details
The voluntary recall now applies to all batches of the following products:
| Product | UPC |
| ByHeart Whole Nutrition Infant Formula Cans | 85004496800 |
| ByHeart Anywhere Pack™ Single-Serve Sticks | 85004496802 |
(Initial batches recalled included Lot Code: 251261P2 and 251131P2 with a “Use by: 01 Dec 2026” date, but the recall is now expanded to ALL products.)
Moving Forward
We understand that switching formulas is stressful, especially during a recall. If you are concerned about finding an alternative formula for your baby, consult your pediatrician immediately. Your healthcare provider is the best resource for guidance on safely switching to an alternative brand that meets your infant’s nutritional needs.
Next Steps and Resources
- ByHeart Contact: Check the official ByHeart website for the latest updates and customer service contact information for refunds/replacements.
- FDA/CDC: Monitor the FDA and CDC websites for the most current information regarding the outbreak investigation.
- Report an Illness: If your child becomes sick, please report it immediately to your healthcare provider and the FDA.
We will continue to follow this story and provide updates as they become available. Please share this crucial information with any parents or caregivers you know.
ByHeart Customer Service & Refund Information
ByHeart has a dedicated team available to assist customers with questions, refunds, and replacements for the recalled formula.
- ByHeart Customer Phone: 1 (833) 429-4327 (Available 24/7)
- ByHeart Customer Email: hello@byheart.com
- Official ByHeart Recall Page: Check the main ByHeart website for the most up-to-date statements and resources for switching formulas.
Refund/Replacement Guidance:
- Consumers who have purchased any ByHeart Whole Nutrition Infant Formula cans or Anywhere Pack™ sticks are advised to immediately discontinue use and dispose of the product.
