The Recall Desk
SevereFDA (Food)·F-1663-2022·Announced 2022-09-07

Abbott PediaSure Harvest 1.0 Cal tube-feeding formula recalled nationwide

Abbott PediaSure Harvest 1.0 Cal tube-feeding formula is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 53,818,025 units with specific lot codes spanning September 2022 through April 2023 are affected.

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 mandates a minimum score of 4. The recall involves two serious foodborne pathogens—Cronobacter sakazakii and Clostridium botulinum—that can cause severe illness, particularly in vulnerable populations using tube-feeding products.

Plain-English summary

Abbott PediaSure Harvest 1.0 Cal is a complete nutrition tube-feeding formula in 8 fl oz (237 mL) bottles manufactured by Lyons Magnus, Inc. for Abbott Nutrition. This product is subject to a Class I FDA recall due to findings and potential contamination with Cronobacter sakazakii and Clostridium botulinum, two bacteria that can cause serious illness.

Approximately 53,818,025 units have been distributed nationwide. Affected products can be identified by specific lot codes with best-by dates ranging from September 1, 2022, through April 1, 2023. The lot codes are printed on both the case packaging and individual bottle labels.

Consumers who have purchased or are using affected lots should consult their healthcare provider immediately for guidance. Anyone with health concerns related to use of this product should report them to the FDA or their healthcare provider.

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
Hazard
  • cronobacter-sakazakii
  • clostridium-botulinum

Distribution

Distributed nationwide across the United States.