The Recall Desk
CriticalFDA (Food)·H-0249-2026·Announced 2025-12-17

Infant formula recalled after contamination with Clostridium botulinum

ByHeart is recalling 3,482,131 cans and 3,531,901 single serve packets of Whole Nutrition Infant Formula after contamination with Clostridium botulinum. The FDA has classified the action as Class I.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

ByHeart Whole Nutrition Infant Formula is being recalled in two formats: 24 oz (680 gram) cans sold in 1, 2, 4 and 6 packs, and Anywhere Packs of 17 gram single serve packets in packages containing 14 packets.

The reason given in the enforcement record is contamination with Clostridium botulinum.

The recall covers 3,482,131 cans and 3,531,901 single serve packets, spanning all batches and codes within expiry from 08NOV2023 to 08NOV2025. Affected UPC codes include 8 50044 96800 8 for a single can, 00850044968893 for the Sam's Club 2-pack, 00850044968053 for the Amazon 2-pack, 8 50044 96802 2 for the Anywhere Pack and 850044968015 for the 1-count sample Anywhere Pack. Distribution was nationwide. The FDA has classified the action as Class I, its most serious category.

Caregivers should stop using affected formula immediately and contact a healthcare provider about a replacement feeding plan. Any infant who has been fed this formula and shows signs of illness should be seen by a healthcare provider without delay.

The recalled product

Product
1. 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
Manufacturer
ByHeart, INC.
Category
Food — Infant formula
Hazard
  • clostridium-botulinum
  • pathogen
  • class-i
  • infant-formula

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Sams Club 2PK: 00850044968893
  • Amazon 2PK: 00850044968053
  • Anywhere pack: 8 50044 96802 2
  • 1-Count Sample Unit Anywhere Pack: 850044968015

Distribution

Distributed nationwide across the United States.

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