(MENAFN- Live Mint) Amid an increasing outbreak of infant botulism, ByHeart on Tuesday voluntarily issued nationwide recall alert for Whole Nutrition infant formula - including cans and a single-serve Anywhere Pack.

The development comes as several infants fell sick in 12 states since August.

Though no deaths have been reported so far, federal health officials said that more cases are pending.

“We are expanding our voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere PackTM nationwide. This action is being taken in close collaboration with the US Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin,” said the company.

Also Read | US cinnamon recall: FDA flags 16 brands for unsafe lead contamination Product Details for Voluntary Recall:

The voluntary recall applies to two batches:

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

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

- Can UPC: 85004496800

- Anywhere PackTM UPC: 85004496802

Where to find batch code?

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

Also Read | FDA recalls Tru-Fru freeze-dried products over potential presence of metal Are other ByHeart products impacted?

No other ByHeart batches are impacted by this voluntary recall.

What should consumers do?

The company advised that consumers who have purchased the formula should immediately discontinue use and dispose of the product.

Will Byheart replace cans?

Yes, ByHeart will replace cans. According to FDA, if you've discarded any formula from the following batches, ByHeart will replace those cans at no cost.

ByHeart co-founders say...

“We're writing to you today to tell you that we have decided to voluntarily recall all ByHeart formula nationwide-this includes both our cans and our single-serve Anywhere PackTM sticks. This decision was made to ensure your baby's safety. It's important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula,” said ByHeart co-founders Mia Funt & Ron Belldegrun in a statement on the site.

They stated that the decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point.

The founders also urged that the most important thing for people to know is that all ByHeart product must be discarded.

The company added that the Parent Experience team is here to help with any of your questions.

What did the FDA say?

- The FDA has an ongoing investigation of infant botulism among babies in the US

- 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.

- ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.

- 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.

What is Infant botulism?

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants. However, it is relatively rare.

According to WHO, it is an intoxication usually caused by ingestion of potent neurotoxins, the botulinum toxins, formed in contaminated foods. Person-to-person transmission of botulism does not occur.

MENAFN11112025007365015876ID1110329075