Recalls / Class I
Class IF-1670-2022
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 1.4 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 11112-03001 0. 12 count case UPC 00811112030027. Shake Well. A ready-to-use oral and tube feeding formula. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708
- Type
- Food
- Affected lot / code info
- EXPANDED 8-10-2022 Lot Code 8031 / Best By Date 11/04/2022
- 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-1670-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.