FDA Food recall ·
1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams recall
This is an FDA Class I recall — the most serious type.
- Recall number
- H-0249-2026
- Date
- (initiated November 8, 2025)
- Company / brand
- ByHeart, INC.
131 Varick St, New York, NY, United States - Category
- Food › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 3,482,131 Cans and 3,531,901 Single Serve Packets.
- Hazard tags
- Botulism Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Contaminated with Clostridium botulinum
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (food), recall H-0249-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.