Agency classClass IOur severity:Severe FDA (Food)·F-1665-2022·Announced 2022-09-07

Pediatric Nutrition Formula Recalled for Bacterial Contamination Risk

Kate Farms Pediatric Peptide formula is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum, high-risk pathogens. The formula is designed for children ages 1 to 13.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The product is a pediatric nutrition formula with potential contamination by high-risk pathogens Cronobacter sakazakii and Clostridium botulinum. No reported illnesses have been documented.

Plain-English summary

Kate Farms Pediatric Peptide 1.0 Cal/mL Vanilla formula is a sole-source nutrition product for children ages 1 to 13 years, designed for oral and tube feeding. The product is being recalled due to findings and potential for Cronobacter sakazakii and Clostridium botulinum.

The product was distributed nationwide. The affected lot is code 2031 with best-by date 10/24/2022. Individual packages contain 250 mL (8.45 fl oz), and cases contain 24 units. Approximately 53,818,025 total units were distributed. The manufacturer is Lyons Magnus, Inc., located at 101 Innovation Place, Santa Barbara, CA 93708.

The recalled product

Product: kate farms Pediatric Peptide 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 11112-03052 2. 24 count case UPC 00811112030539. A Oral and Tube Feeding Formula. Specifically designed for children ages 1-13 years old. Not suitable for infants…
Manufacturer: Lyons Magnus, Inc
Category: Food — Pediatric Nutrition Formula
Hazard: cronobacter-sakazakii
clostridium-botulinum
Affected units: 53,818,025

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 (1)

EXPANDED 8-10-2022 Lot Code 2031 / Best By Date 10/24/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 77 recalled by Lyons Magnus, Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 77 products in this recall →

Same manufacturer · Lyons Magnus, Inc

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Same hazard · cronobacter sakazakii