Organic baby formula maker ByHeart has announced a nationwide recall of all its infant formula products after at least 15 cases of infant botulism were reported across a dozen U.S. states. The company and federal health officials are urging parents to stop using the products immediately as investigations continue.

What triggered ByHeart’s nationwide recall?

The recall marks a major escalation from the company’s earlier weekend action, when ByHeart pulled two product batches after federal health officials linked several infant hospitalizations to its formula. By Monday night, the company said it had been notified of 15 suspected cases of infant botulism — though none have resulted in death so far.

The illnesses have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, among other states.

ByHeart said the decision to recall all its formula products was made “out of an abundance of caution,” emphasizing that no contamination has yet been confirmed.

“This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information,” said Mia Funt, ByHeart’s co-founder and president. She added that the company has launched an independent investigation and is testing all batches of its formula at a third-party lab.

What products are affected?

The recall covers ByHeart Whole Nutrition Infant Formula and the company’s Anywhere Pack travel pouches, which together account for over 200,000 cans sold each month nationwide.

Parents and caregivers are being urged to check their pantry for any ByHeart-branded formula, dispose of it safely, and contact the company for refunds or replacement guidance.

The U.S. Food and Drug Administration (FDA) noted that ByHeart products make up less than 1% of the total baby formula market, assuring that the recall “does not create shortage concerns.”

This comes as parents recall the 2022 baby formula shortage, which followed the temporary shutdown of an Abbott Nutrition plant due to contamination fears — a crisis that left many struggling to find suitable alternatives.

What is infant botulism, and why is it dangerous?

Infant botulism is a rare but serious illness caused by Clostridium botulinum, a bacterium that produces toxins affecting the nervous system.

When babies ingest spores of the bacteria, often through contaminated food, these spores can multiply inside their intestines and produce toxins that lead to paralysis.

Common symptoms include:

• Constipation
• Weak cry or loss of head control
• Difficulty swallowing or feeding
• Muscle weakness
• Breathing problems or respiratory arrest

According to the Centers for Disease Control and Prevention (CDC), infant botulism typically affects babies between 2 weeks and 5 months old. Treatment involves hospitalization and the use of specialized intravenous medication.

What are health officials doing?

The California Department of Public Health first alerted the CDC about possible botulism cases tied to ByHeart’s products. Preliminary tests on a can of ByHeart formula used by one sick infant reportedly indicated the presence of Clostridium botulinum.

Several other states have since sent leftover formula samples for testing, with results expected in the coming weeks, according to the FDA.

As of now, no unopened cans of ByHeart formula have been conclusively shown to contain the bacteria, and officials caution that the outbreak could be part of a broader rise in infant botulism cases unrelated to a single product.

ByHeart’s safety record under scrutiny

This is not the first time ByHeart has faced regulatory challenges.

• In late 2022, the company recalled several batches of formula after detecting a different bacterium at a contracted manufacturing facility.
• In 2023, the FDA issued a warning letter citing safety violations and outlining corrective steps required before operations could continue.
• The company has since ceased working with that manufacturer and acquired two new facilities to ensure greater oversight and product safety.

ByHeart markets its formula as being made from organic, grass-fed whole milk and designed to resemble the nutritional profile of breast milk — claims that have helped it gain a loyal customer base among health-conscious parents.

What parents should do now?

The FDA advises parents who purchased ByHeart formula to:

1. Stop using the products immediately.
2. Check the company’s website or call its customer support line for refund instructions.
3. Monitor infants for any signs of botulism, including lethargy, constipation, or feeding difficulties.
4. Seek immediate medical attention if symptoms appear.

Healthcare professionals are also being urged to report suspected cases of infant botulism to the CDC and local health departments promptly.

TL;DR

• ByHeart recalls all baby formula products after 15 cases of infant botulism in 12 states.
• The company says no contamination has been confirmed, but is recalling products as a precaution.
• The FDA says there’s no risk of a nationwide formula shortage.
• Infant botulism is a rare but potentially fatal illness caused by Clostridium botulinum.
• Parents are urged to stop using ByHeart formula and contact the company for guidance.