RecallHawk
Class I Recall

kate farms Standard 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00663 8. 12 co

Lyons Magnus, Inc

Summary

The FDA issued a Class I for kate farms Standard 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 325 mL by Lyons Magnus, Inc. Reason: Findings and potential for Cronobacter sakazakii and Clostridium botulinum..

Details

Source

Food Recall

External ID

F-1666-2022

Action Date

2022-09-07

Status

Terminated

Category

food

Product Description

kate farms Standard 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00663 8. 12 count case UPC 00851823006683. Shake Well. A ready-to-use oral and tube feeding formula with intact organic pea protein. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708

Lot/Code Info: EXPANDED 8-10-2022 Lot Code 5621 / Best By Date 09/17/2022 Lot Code 6621 / Best By Date 09/18/2022 Lot Code 7621 / Best By Date 09/19/2022

Quantity Affected: 53,818,025 total units

Reason for Recall

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Distribution

Nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2022-07-22

Company

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 111 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Lyons Magnus, Inc has 78 FDA actions in our database, including 78 recalls.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lyons Magnus, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Lyons Magnus, Inc have FDA actions?

Lyons Magnus, Inc has 78 FDA actions in our database, including 78 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-1666-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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