ByHeart Whole Nutrition Infant formula recalled due to Clostridium Botulinum

United States

Update December 23rd, 2025:
ByHeart released a new public statement confirming additional findings and next steps in its ongoing investigation into the infant botulism outbreak.

TESTING RESULTS UPDATE: Third-party testing conducted by IEH Laboratories confirmed positive results for Clostridium botulinum Type A in six of 36 tested samples, taken from two previously recalled batches (Batch 251261P2 and Batch 251131P2). Results were confirmed using whole-genome sequencing.

SCOPE OF RECALL REMAINS UNCHANGED: All ByHeart infant formula products nationwide, including cans and Anywhere Pack™ sticks, remain recalled while the investigation continues.

ROOT CAUSE INVESTIGATION ONGOING: ByHeart stated it is operating under the assumption that any part of its supply chain could be a potential contamination point and continues comprehensive audits, environmental testing, and supply-chain reviews with external food safety experts.

REFUND POLICY REAFFIRMED: Full refunds continue to be available for all purchases made on the ByHeart website on or after August 1, 2025, with customer support available via phone.

The company emphasized its commitment to transparency and stated that additional updates will be shared as new findings emerge.

Source: ByHeart


Update December 10th, 2025:
The recall was classified as Class I.

Source: www.accessdata.fda.gov/scripts/ires/index.cfm


Update November 24th, 2025:
ByHeart has issued new information for families, including an expanded refund policy and updated findings related to the contaminated product.

Refund policy expanded:
ByHeart will now provide full refunds for all purchases made on ByHeart.com on or after August 1, 2025. This revision is based on updated FDA data indicating the earliest illness in the outbreak began on August 9. Families can request refunds by calling the company’s 24/7 support line. Refunds are expected to be issued within 5–7 business days after contacting customer support.

Contamination update:
ByHeart reiterated that testing performed with IEH Laboratories found positive results for Clostridium botulinum Type A in five of 36 samples across three lots of unopened formula. Because contamination cannot be ruled out across all lots, the company continues to advise families to stop using all ByHeart formula immediately. Additional testing and a full supply-chain audit are underway.

Retail availability concerns:
The company addressed ongoing reports of recalled formula still being found at some retail locations. ByHeart stated that all retailers were notified to remove products from shelves, and checkout systems should block any remaining inventory from being sold. They note that the FDA has also issued retailer notifications.

Source: ByHeart


Update November 19th, 2025:
ByHeart has announced that third-party laboratory testing detected Clostridium botulinum in some samples of ByHeart formula, marking the first confirmed detection associated with the ongoing infant botulism investigation. The company immediately notified the FDA and stated that additional testing and a full internal review are underway to identify the source of contamination.

ByHeart reports that it is now conducting a comprehensive evaluation of its entire production chain, including ingredient sourcing, manufacturing, packaging, transport, and facility operations. Independent experts in microbiology and food safety have been brought in to support the investigation.

The company also emphasized that Clostridium botulinum had not previously been part of routine industry testing, and it is working with the FDA to improve testing standards and develop stronger safeguards industry-wide.

ByHeart continues to urge families to stop using all recalled ByHeart formula products immediately and seek medical care if infants show symptoms of botulism. The company has expanded customer support and will update its Safety & Education Hub as new information becomes available.

Further updates will be provided as the investigation progresses.

Source: byheart.com/pages/an-update-from-our-founders-on-our-voluntary-recall-november-2025


Update November 11th, 2025:
ByHeart has expanded its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula (24 oz cans) and Anywhere Pack™ (0.6 oz packets) distributed nationwide, as the FDA’s investigation into the infant botulism outbreak continues.

No unopened ByHeart products have tested positive for Clostridium botulinum spores or toxin, but the company is taking this action out of an abundance of caution and in collaboration with the FDA. ByHeart is:

- Recalling all products from the market while the FDA completes testing.
- Conducting third-party testing on every batch of formula.
- Providing full access to FDA and the California Department of Public Health for inspection and testing.
- Committing to publicly share all testing results.

RECALLED PRODUCTS:
- ByHeart Whole Nutrition Infant Formula, all batch codes, 24 oz cans (UPC: 85004496800)
- ByHeart Anywhere Pack™, all batch codes, 0.6 oz packets (UPC: 85004496802)

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-broadens-voluntary-recall-while-investigation-continues


November 8th, 2025:
ByHeart, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism. The affected product was distributed across the US. ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point.

The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.

Product Details for Voluntary Recall:
The voluntary recall applies to the following two batches of ByHeart infant formula:
- Batch Code: 251261P2, Use by: 01 Dec 2026
- Batch Code: 251131P2, Use by: 01 Dec 2026
- UPC: 5004496800

The batch code and use by can be found on the bottom of the can.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/response-broader-fda-investigation-byheart-initiates-voluntary-recall-two-batches-infant-formula