Last updated on November 25th, 2025 at 09:43 am
URGENT RECALL: As of November 8th, 2025 a proactive, voluntary recall of 2 batches of ByHeart’s infant formula have been recalled.
Which batches are affected by the ByHeart formula recall?
- Batch Code: 251261P2, Use by: 01 Dec 2026
- Batch Code: 251131P2, Use by: 01 Dec 2026
- UPC: 5004496800
If you use this infant formula for your twins or other children, you can find the batch number listed on the bottom of the can. For more information about the Whole Nutrition Infant Formula recall, click here.
Why are these batches of ByHeart formula being recalled?
Since August 2025, the U.S. FDA has been tracking 83 cases of infant botulism. Botulism is caused by unknowingly consuming Clostridium botulinum spores, and it can cause serious harm (and even death) in infants because they have an immature gut.
Up until now, there has never been an instance of baby formula causing botulism. Typically, Clostridium botulinum spores live in dust and soil and can contaminate foods. The most well-known food-borne cause of infant botulism is honey.
In recent days, the FDA contacted ByHeart Inc. informing them that in 13 of these 83 cases of infant botulism, the infants had been using the ByHeart’s Whole Nutrition Infant Formula. The recalled batches of this formula are still being investigated out of caution, and the FDA will continue to report updates once they are able to gather more conclusive data.
For now, if you use this formula, be sure to check your can for the batch number, and make sure to educate yourself about infant botulism if you’re not yet familiar with what it is.
Here are major signs and symptoms of infant botulism to look out for:
- Constipation
- Difficulty feeding, sucking, and swallowing
- Drooping or sluggish pupils
- Low muscle tone
- A look of fatigue or general weakness
- A weak cry
- Respiratory distress
If you ever suspect your baby has botulism, go to the nearest emergency room right away as it can turn out to be life-threatening.
Where can I find more information about the ByHeart formula recall?
- You can read ByHeart’s formal statement about the recall here.
- You can read the FDA’s investigation summary about the recall here.
- You can read more about the infant botulism outbreak on the CDC website here.
Want to read more about infant formula? Check out these articles too:
- 11 Formula Feeding Must-Haves
- Organic vs. Non-Organic Formula: Deciding What is Best for Your Baby
- 3 Ways to Get Free Formula For Your Twins
