Class IF-1666-2022

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

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

Type: Food
Affected 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: 53,818,025 total units

Why it was recalled

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Recalling firm

Firm: Lyons Magnus, Inc
Notification channel: Telephone
Type: Voluntary: Firm initiated
Address: 3158 E Hamilton Ave, Fresno, California 93702-4163

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-07-22
FDA classified: 2022-08-30
Posted by FDA: 2022-09-07
Terminated: 2024-07-25
Status: Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1666-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.