Class IF-1665-2022

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 Pediatric Peptide 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 11112-03052 2. 24 count case UPC 00811112030539. A Oral and Tube Feeding Formula. Specifically designed for children ages 1-13 years old. Not suitable for infants less than 1 year old. Shake vigorously. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708

Type: Food
Affected lot / code info: EXPANDED 8-10-2022 Lot Code 2031 / Best By Date 10/24/2022
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-1665-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.