Kate Farms Nutrition Formula Recalled for Cronobacter and Botulinum Risk
Kate Farms Standard nutrition formula in 325 mL bottles is being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 53,818,025 units distributed nationwide.
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 requires a minimum severity score of 4. The recall involves high-risk pathogens Cronobacter sakazakii and Clostridium botulinum, which can cause serious illness. No illnesses are reported in the source text.
Plain-English summary
Kate Farms Standard 1.0 Cal/mL Vanilla Sole-Source Nutrition Formula in 325 mL bottles is being recalled by the FDA. The product is manufactured by Lyons Magnus, Inc. for Kate Farms, Inc., located in Santa Barbara, California.
The recall was initiated due to findings and potential for contamination with Cronobacter sakazakii and Clostridium botulinum. This is a Class I recall.
The affected product has lot codes 5621 (Best By 09/17/2022), 6621 (Best By 09/18/2022), and 7621 (Best By 09/19/2022). Approximately 53,818,025 units have been distributed nationwide.
The recalled product
- 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…
- Manufacturer
- Lyons Magnus, Inc
- Category
- Food — Medical Nutrition Formula
- 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.
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