New York Baby Nutrition Company Issues Nationwide Recall for Potentially Contaminated Products

In the last week, one described next-generation baby nutrition company has been in the midst of handling a serious recall of their baby formula products that may potentially have been contaminated with a dangerous spore that could cause series health problems for infants. The recall issued for the products is part of a broader investigation into multiple baby's who have gotten sick over the last few months with a potentially fatal illness.

Baby Formula Recall

The baby formula that is subject to the recall is the Whole Nutrition Infant Formula made by ByHeart, a company who's headquarters is located here in New York, and has multiple facilities across the U.S. that produce their baby formula products. ByHeart was reportedly notified of the potential contamination with their products last week on November 7, 2025, and since then has worked closely with the FDA (Food & Drug Administration) in handling the recall, and has issued multiple updates on the rapidly changing situation.

In the press release issued by the FDA, it states that they have been investigating a recent outbreak of infant botulism that has broken out across the U.S. Infant botulism while rare, is a potentially fatal illness that presents a serious threat to the health of infants. It occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

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Since August of 2025, there have been 83 reported cases of infant botulism reported nationwide. The FDA also stated that they have NOT identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism. Of the cases reported, 13 of them involved infants who had at one point received ByHeart formula.

ByHeart in working in conjunction with the FDA issued the recall nationwide of both the implicated products voluntarily out of an abundance of caution. At this time, no ByHeart products have tested positive for any contaminants.

Formula Products

The ByHeart formula products recalled were made in two separate batches. The first batch according to the first press release from ByHeart, was produced on April 23, 2025, and the second was produced on May 6, 2025.

The products can be identified by their batch codes, UPC code and use by date. Those codes are as follows...

• Batch Code: 251261P2, Use by: 01 Dec 2026
• Batch Code: 251131P2, Use by: 01 Dec 2026
• UPC: 85004496800

Mia Funt, the Co-Founder and President of ByHeart had the following to say regarding the recall and ByHearts immediate response. The full response from Hunt can be read in the FDA press release linked above.

The safety and well-being of every infant who uses our formula is our absolute highest priority. We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise....

Customer Response

As has been the case previously with other recalls, customers who purchased the recall implicated formula have multiple options in terms of what they can do. First and foremost, both the FDA and ByHeart each recommend that consumers who have purchased the infant formula from the identified batch codes should immediately discontinue use and dispose of the product. In addition, ByHeart will also replace any discarded formula at no cost.

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It's recommended that for anyone who's infant has shown signs of infant botulism, that they contact their health care provider immediately. ByHeart's Parent Experience team can be contacted for support at 866-201-9069, and more information can be found at byheart.com. The FDA is also available at (833) 429 - 4327.