ByHeart Issues Voluntary Recall of Five Batches of Its Infant Formula Because of Possible Health Risk

ByHeart Issues Voluntary Recall of Five Batches of Its Infant Formula Because of Possible Health Risk
  • Company: ByHeart
  • Product: Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months
  • Status: inactive
  • Type: Milk
  • Date: Dec 11, 2022
  • Reason: Potential for cross-contamination with Cronobacter sakazakii

Raleigh, N.C., Jan. 14, 2026 — ByHeart has voluntarily recalled five batches of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron (24 oz) because of a potential cross-contamination risk with Cronobacter sakazakii; consumers should stop using the identified cans immediately and dispose of or return them. The company says none of its distributed product has tested positive and no illness complaints have been received to date, but is taking the precautionary action after one test sample from a third‑party canning facility tested positive. Cronobacter can cause severe infections in infants, including sepsis and meningitis; parents with symptomatic infants should seek immediate medical care.

The recalled products are identified by lot code(s) 22273 C1, 22276 C1, 22277 C1, 22278 C1 and 22280 C1 and are printed with use‑by 01 JAN 24 or 01JUL 24 on the bottom of the can. These cans have been sold directly to consumers online and at select U.S. retailers and have been sold since Sept. 15, 2025; customers should check the bottom of the can to confirm whether their product is included in the recall. ByHeart states the recall is not related to its Reading, Pa., manufacturing facility, which continues to operate and supply product.

Consumers should either dispose of affected cans or return them for a refund or replacement and may request assistance by emailing [email protected] or texting 1-909-506-2354; the company is also contacting customers who purchased the identified batches. ByHeart is offering to cover the cost of two cans of alternate formula as the fastest replacement option and will provide two free cans of ByHeart Whole Nutrition Formula with the next order for affected customers. For suspected illnesses or to report an adverse event, contact your health care provider and consider reporting to FDA via the Consumer Complaint Coordinator or MedWatch; visit the company website notices page for additional information.

Read More
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-issues-voluntary-recall-five-batches-its-infant-formula-because-possible-health-risk
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