PlainRecalls
FDA Food Verify with FDA Food → Critical Class I Terminated

kate farms Peptide 1.5 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00646 1. 12 count case UPC 00851823006379. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708

Reported: September 7, 2022 Initiated: July 22, 2022 #F-1671-2022 53,818,025 total units units

Lyons Magnus, Inc issued this FDA Food recall on September 7, 2022. Classified as Critical severity (Class I). Approximately 53,818,025 total units units are affected. The recall was issued because: Findings and potential for Cronobacter sakazakii and Clostridium botulinum.. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Food action (record #F-1671-2022) was formally reported on September 7, 2022, with the manufacturer initiating the action on July 22, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Lyons Magnus, Inc is listed as the recalling firm, operating out of Fresno, CA. Federal records indicate 53,818,025 total units units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Findings and potential for Cronobacter sakazakii and Clostridium botulinum. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Critical

Units Affected

53,818,025 total units

Related Recalls

6

6 from same agency

Product Description

kate farms Peptide 1.5 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00646 1. 12 count case UPC 00851823006379. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708

Reason for Recall

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Details

Recalling Firm
Lyons Magnus, Inc
Units Affected
53,818,025 total units
Distribution
Nationwide
Location
Fresno, CA

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number F-1671-2022
Date reported September 7, 2022
Date initiated July 22, 2022
Recalling firm Lyons Magnus, Inc
Units affected 53,818,025 total units
Distribution Nationwide

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

53,818,025 total units units affected — million-unit bracket.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
kate farms Peptide 1.5 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00646 1. 12 count case UPC 00851823006379. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708. Recalled by Lyons Magnus, Inc. Units affected: 53,818,025 total units.
Why was this product recalled?
Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Which agency issued this recall?
This recall was issued by the FDA Food on September 7, 2022. Severity: Critical. Recall number: F-1671-2022.
Where was the recalled product distributed?
Distribution: Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (F-1671-2022) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product?
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).