The Recall Desk
SevereFDA (Food)·F-1672-2022·Announced 2022-09-07

Kate Farms Pediatric Peptide Formula Recalled for Bacterial Contamination

Lyons Magnus is recalling kate farms Pediatric Peptide formula nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. The recall affects 53.8 million units of this ready-to-use pediatric nutrition formula.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, the highest agency classification, establishing a minimum severity of 4. The potential contamination involves two serious bacterial pathogens (Cronobacter sakazakii and Clostridium botulinum) in a pediatric nutrition formula. However, no illnesses, injuries, or deaths are reported in the source material.

Plain-English summary

Lyons Magnus, Inc., is recalling kate farms Pediatric Peptide 1.5 Cal/mL Vanilla formula nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination. This ready-to-use oral and tube feeding formula, designed as sole-source nutrition for infants and children, was widely distributed.

The nationwide recall affects 53,818,025 total units sold in 250 mL ready-to-use bottles packaged in 12-count cases. The affected lots are identified by code numbers 0031, 1031, 3221, 3531, 4221, 4531, 6131, 6721, and 7131, with best-by dates ranging from August 11, 2022 through December 20, 2022.

Consumers currently using this formula should discontinue use immediately and consult with a healthcare provider. Parents and caregivers should not use any affected lot codes. Healthcare providers treating patients who have consumed this product should monitor for potential illness and report any adverse health events to the FDA.

The recalled product

Product
kate farms Pediatric Peptide 1.5 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 51823-00687 4. 12 count case UPC 00851823006201. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for
Manufacturer
Lyons Magnus, Inc
Category
Food — Pediatric Nutrition Formula
Hazard
  • cronobacter-sakazakii
  • clostridium-botulinum

Distribution

Distributed nationwide across the United States.

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