ByHeart Whole Nutrition Infant Formula Recall: FDA Warns of Botulism Risk
ByHeart has issued a nationwide, voluntary recall of two production batches of its Whole Nutrition Infant Formula after the U.S. Food and Drug Administration (FDA) opened an investigation into a cluster of infant botulism cases. No ByHeart product has tested positive for Clostridium botulinum, but the company is acting “out of an abundance of caution.”
Reason for the ByHeart Infant Formula Recall
Since late 2025, the FDA has documented 83 cases of infant botulism in the United States. Thirteen of those infants had consumed ByHeart formula. While testing has not confirmed contamination in any ByHeart products, spores of C. botulinum can survive in low-acid foods such as powdered formula. Because botulism can cause paralysis and respiratory failure in babies, the FDA asked the manufacturer to remove the suspect batches from sale.
Recalled ByHeart Formula Batches
- Batch codes: 251261P2 and 251131P2 (printed on can bottom)
- Size: 24-oz (680 g) cans
- Use-by date: 01 Dec 2026
- UPC: 5004496800
- Product name: ByHeart Whole Nutrition Infant Formula
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What Parents and Caregivers Should Do Now
- Immediately stop feeding the recalled ByHeart formula to your baby.
- Dispose of any cans from the affected batches.
- Request a free replacement or refund 24/7 by emailing hello@byheart.com or calling 1-833-429-4327.
- Watch for botulism symptoms: constipation, weak cry, poor feeding, drooping eyelids, or breathing difficulties. Contact a healthcare professional at once if any appear.
- Report suspected illnesses to the FDA through the MedWatch online form or your regional Consumer Complaint Coordinator.
Official Photos of the Recalled ByHeart Formula
Stay Updated on the ByHeart Recall
For ongoing information, visit the FDA’s outbreak advisory page or the manufacturer’s website at ByHeart.com. The company states no other ByHeart batches or products are affected.
ByHeart Formula Recall FAQ
What specific ByHeart formula is recalled?
The recall covers ByHeart Whole Nutrition Infant Formula in 24-oz cans from batches 251261P2 and 251131P2.
How do I confirm my ByHeart can is part of the recall?
Turn the can over and check the batch code and use-by date. If the code is 251261P2 or 251131P2 with a 01 Dec 2026 use-by date, dispose of the product.
Why recall ByHeart formula if no contamination was detected?
Although laboratory tests found no C. botulinum in ByHeart formula, the FDA is investigating a broader botulism outbreak. Voluntary recalls help protect infants while the investigation continues.
Has any infant illness been directly linked to ByHeart formula?
To date, no causal link has been confirmed. Thirteen infants with botulism had consumed ByHeart formula, but the FDA has not detected the pathogen in the product.
Will ByHeart replace or refund the recalled formula?
Yes. Contact ByHeart at 1-833-429-4327 or hello@byheart.com for free replacement cans or a refund.
How do I report illness related to the ByHeart recall?
File a report with the FDA’s MedWatch program or speak with your regional Consumer Complaint Coordinator.
Is any other ByHeart product affected by this recall?
No. The voluntary recall is limited to the two batch codes listed above.