Agency classClass IOur severity:Severe FDA (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.

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 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.…
Manufacturer: Lyons Magnus, Inc
Category: Food — Infant Formula / Tube Feeding
Hazard: cronobacter-sakazakii
clostridium-botulinum
Affected units: 53,818,025

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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