Severity
Critical
CriticalClass IOngoing
FDA Food recall · Reported December 17, 2025
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
Contaminated with Clostridium botulinum
Compiled from official public sources by the editorial team.
Verify with FDA Food →
ByHeart, INC. recalled 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 pa… - a critical-severity action.
1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 pa… was recalled by ByHeart, INC. in December 17, 2025. Reason: Contaminated with Clostridium botulinum. Check the official notice for the remedy. Verify recall #H-0249-2026 with the FDA Food before acting.
The recall
ByHeart, INC. issued this critical-severity FDA Food recall-Contaminated with Clostridium botulinum.
- Critical
- severity level
- Class I
- classification
- December 17, 2025
- reported
Sourced from official FDA Food enforcement records. Verify recall #H-0249-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #H-0249-2026) was formally reported on December 17, 2025, with the manufacturer initiating the action on November 8, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. ByHeart, INC. is listed as the recalling firm, operating out of New York, NY. Federal records list the affected scope as 3,482,131 Cans and 3,531,901 Single Serve Packets..
The documented reason for this recall is: Contaminated with Clostridium botulinum Distribution data in the federal record shows the product reached: nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,482,131 Cans and 3,531,901 Single Serve Packets.
Related Recalls
6
0 from same agency
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
Reason for recall
Contaminated with Clostridium botulinum
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | H-0249-2026 |
| Date reported | December 17, 2025 |
| Date initiated | November 8, 2025 |
| Recalling firm | ByHeart, INC. |
| Firm location | New York, NY |
| Affected scope | 3,482,131 Cans and 3,531,901 Single Serve Packets. |
| Distribution | nationwide |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (H-0249-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ByHeart, INC.. Units affected: 3,482,131 Cans and 3,531,901 Single Serve Packets..
Why was this product recalled? ▼
Contaminated with Clostridium botulinum
Which agency issued this recall? ▼
This recall was issued by the FDA Food on December 17, 2025. Severity: Critical. Recall number: H-0249-2026.
Where was the recalled product distributed? ▼
Distribution: nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (H-0249-2026) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported December 17, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.