The Recall Desk
SevereFDA (Food)·F-1664-2022·Announced 2022-09-07

Abbott PediaSure Harvest infant nutrition recalled for bacterial contamination

Abbott PediaSure Harvest 1.0 Cal formula is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.

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: FDA Class I classification requires a minimum score of 4. The identified pathogens, Cronobacter sakazakii and Clostridium botulinum, are high-risk organisms capable of causing serious illness. No illnesses have been reported, but the findings of these dangerous pathogens in a product used for vulnerable tube-feeding patients justifies the Severe classification.

Plain-English summary

Abbott PediaSure Harvest 1.0 Cal, a complete nutrition blend for tube feeding in 8 fl oz (237 mL) containers, is being recalled nationwide. The product is manufactured by Lyons Magnus, Inc for Abbott Nutrition.

The recall was classified as FDA Class I due to findings of potential contamination with Cronobacter sakazakii and Clostridium botulinum. These are serious bacterial pathogens capable of causing severe illness. The recall affects 53,818,025 total units distributed nationally, with specific lot codes and best-by dates ranging from September 2022 through April 2023.

Consumers with affected products should consult their healthcare provider. Retailers and healthcare facilities should check lot codes and remove affected products from distribution.

The recalled product

Product
Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufact
Manufacturer
Lyons Magnus, Inc
Category
Food — Nutritional Formula / Tube Feeding
Hazard
  • cronobacter-sakazakii
  • clostridium-botulinum

Distribution

Distributed nationwide across the United States.

Related recalls

Same category