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Infant nutrition brand ByHeart has recalled two batches of its Whole Nutrition Infant Formula following notification from the FDA about an ongoing investigation into the recent outbreak of infant botulism in the US.

A statement released on Saturday (8 November 2025) by California's Department of Public Health (CDPH) said that preliminary testing of one sample of the formula, carried out at its laboratory, suggested the presence of Clostridium botulinum, the bacterium that causes botulism.

Erica Pan, CDPH director and State Public Health Officer, said: "Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time".

Pan added: "We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately."

According to the FDA, 83 cases of infant botulism have been reported nationwide since August, with 13 infants having received ByHeart formula at some point.

There has been no historical precedent of infant formula causing infant botulism, which is extremely rare and originates from environmental sources such as soil, dust or certain vegetables.

A statement shared on 9 November, by ByHeart co-founders Mia Funt and Ron Belldegrun, said ByHeart is treating the CDPH's preliminary result "with the utmost seriousness," and is now conducting testing, with a third party independent testing laboratory, of the two recalled batches of its formula.

However, the co-founders said the positive sample tested by the CDPH came from a previously-opened can. Due to this, they stated that the testing "lacks scientific basis to establish causation between the product and illness".

"We know that Clostridium botulinum is a bacteria that exists naturally in the environment – in places like soil, dust, and even vegetables – meaning that an opened can can be contaminated in multiple ways," the statement added.

The voluntary recall applies only to the following batches:

• Batch Code: 251261P2 - Use by: 01 Dec 2026

• Batch Code: 251131P2 - Use by: 01 Dec 2026

• UPC: 5004496800

The batch code and use-by date can be found on the bottom of the can. No other ByHeart products or batches are affected by this recall.

Consumers who have purchased cans from the identified batches have been advised to discontinue use immediately and dispose of the product. ByHeart has committed to replacing affected cans and providing two additional cans at no cost to customers who have discarded recalled products.

ByHeart entered the infant formula market in 2022, with a vertically integrated manufacturing model. The company stated that it continues to meet or exceed both US and global product safety standards.

Parents are advised to contact their doctor immediately if their infant shows symptoms such as constipation, poor feeding, a weak cry, drooping eyelids or respiratory difficulty.