CLASS I ONGOING Food recall · Reported 17 Dec 2025 · FDA Enforcement Report

ByHeart Whole Nutrition Infant Formula recalled

ByHeart is recalling ByHeart Whole Nutrition Infant Formula, distributed nationwide in the US. The recall was initiated on 8 Nov 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll 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 recalled3,482,131 Cans and 3,531,901 Single Serve Packets.

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: H-0249-2026
FDA event ID: 97959
Recalling firm: ByHeart, New York, NY
Classification: Class I
Status: Ongoing
Recall initiated: 8 Nov 2025
FDA classified: 10 Dec 2025
Reported: 17 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Botulism
Product category: Baby Formula

Timeline

8 Nov 2025	Recall initiated by company
10 Dec 2025	Classified by FDA	+32 days
17 Dec 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Contaminated with Clostridium botulinum

Product as listed by the FDA

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

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

Contaminated with Clostridium botulinum

Which lots are affected?

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

Where was it sold?

nationwide

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ByHeart

All 2

Reported	Class	Recall	Company	Reason	Where
25 Jan 2023Food	CLASS I	By Heart Whole Nutrition Infant Formula recalledBy Heart	ByHeart	Cronobacter	Nationwide

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