1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByH
Summary
The FDA issued a Class I for 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 p by ByHeart, INC.. Reason: Contaminated with Clostridium botulinum.
Details
Source
Food Recall
External ID
H-0249-2026
Action Date
2025-12-17
Status
Ongoing
Category
food
Product Description
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
Lot/Code Info: 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
Quantity Affected: 3,482,131 Cans and 3,531,901 Single Serve Packets.
Reason for Recall
Contaminated with Clostridium botulinum
Distribution
nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-08
Company
New York, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 105 food recalls issued in the same week, part of 204 food-related FDA actions this month.
ByHeart, INC. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ByHeart, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ByHeart, INC. have FDA actions?
ByHeart, INC. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0249-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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