RECALL DATABASE

Infant Formula Recall: ByHeart Cans

Announced 2025-12-17 · FDA

FDA recalls ByHeart Whole Nutrition Infant Formula due to contamination with Clostridium botulinum. The recall covers 3,482,131 cans and 3,531,901 single-serve packets sold nationwide; UPC codes and expiry dates are listed in the recall notice.

BrandByHeart, INC.
Product1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve Packets
ReasonContaminated with Clostridium botulinum
Severitycritical
Units affected3482131
Distributionnationwide
AgencyFDA
Recall / campaign no.All batches and codes within expiry Finished Product Quantity 08NOV2023 to 08NOV2025 UPC Codes: Single Can: 8 50044 96800 8; Sams Club 2PK: 00850044968893; Amazon 2PK: 00850044968053; Anywhere pack: 8 50044 96802 2; 1-Count Sample Unit Anywhere Pack: 850044968015

WHAT YOU SHOULD DO

  1. Do not use any recalled ByHeart Whole Nutrition Infant Formula products.
  2. Check the UPC codes and expiry dates in the recall notice; discard or return any matching items.
  3. If your infant has consumed recalled product or shows symptoms such as feeding difficulties or vomiting, contact a healthcare professional immediately.
  4. For guidance on refunds or replacements, contact ByHeart customer service or the retailer.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.