Infant Formula Recalled Due to Potential Clostridium Botulinum Contamination
On November 11, 2025, ByHeart Inc. announced a recall of all ByHeart Whole Nutrition Infant Formula products. This recall is due to possible Clostridium botulinum contamination.
Affected products were sold nationwide. Affected products were sold as cans of formula and single serve packets. The UPC of the cans is 85004496800 and the UPC of the Anywhere Packs is 85004496802.
Clostridium botulinum can cause signs including constipation, poor feeding, drooping eyelids, sluggish pupils, difficulty sucking and swallowing, weak or altered cry, respiratory difficulty, generalized weakness, and possible respiratory arrest. If these symptoms are experienced, seek medical attention immediately. Consumers with a child experiencing illness or adverse effects may report them by calling an FDA Consumer Complaint Coordinator or completing a Voluntary MedWatch form. These forms may be completed either online or on paper and mailed in.
Consumers who have these products should discontinue their use immediately and dispose of the product.
For any questions or concerns, consumers may contact ByHeart at hello@byheart.com or 1-(833) 429-4327 at any time 24/7. The FDA Consumer Complaint Coordinators may be contacted at 1-888-INFO-FDA, and the Voluntary MedWatch form may be accessed at https://www.accessdata.fda.gov/scripts/medwatch/.
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