Whole Nutrition Infant formula

  • Potential Foodborne Illness – Clostridium botulinum
  • Company: ByHeart Inc.
  • Food & Beverages
  • FDA
  • November 8, 2025

Product details

  • Whole Nutrition Infant formula

Company announcement

ByHeart is voluntarily recalling two batches of infant formula due to a potential risk of contamination with Clostridium botulinum.

The FDA has an ongoing investigation of infant botulism among babies in the U.S. and has noted that 13 infants received ByHeart formula at some point.

No direct link between infant formula and these cases has been identified, and there is no historical precedent of infant formula causing infant botulism.

There have been no reported illnesses related to this recall.

Risk:

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

Impacted states: Nationwide

Products:

- ByHeart Whole Nutrition Infant Formula (UPC code(s): 5004496800)

- ByHeart Whole Nutrition Infant Formula (UPC code(s): 5004496800)

Contact

For more information, call (833) 429-4327 or email hello@byheart.com..

View the original FDA notice

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