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FDA Food Verify with FDA Food → Critical Class I Terminated

Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak

Reported: May 29, 2024 Initiated: April 18, 2024 #F-1248-2024 2,487 units of 0.64oz Stick Paks units

Graceleigh, Inc. dba Sammy's Milk issued this FDA Food recall on May 29, 2024. Classified as Critical severity (Class I). Approximately 2,487 units of 0.64oz Stick Paks units are affected. The recall was issued because: FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials…. 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-1248-2024) was formally reported on May 29, 2024, with the manufacturer initiating the action on April 18, 2024. It is classified under Critical severity (Class I), with a current status of Terminated. Graceleigh, Inc. dba Sammy's Milk is listed as the recalling firm, operating out of Newport Beach, CA. Federal records indicate 2,487 units of 0.64oz Stick Paks 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: FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for… Distribution data in the federal record shows the product reached: U.S. Distribution to the following states: AL, AK, AZ, AK, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, WY. …. 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 2 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

2,487 units of 0.64oz Stick Paks

Related Recalls

6

6 from same agency

Product Description

Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak

Reason for Recall

FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.

Details

Units Affected
2,487 units of 0.64oz Stick Paks
Distribution
U.S. Distribution to the following states: AL, AK, AZ, AK, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, WY. All sales direct to consumer.
Location
Newport Beach, 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-1248-2024
Date reported May 29, 2024
Date initiated April 18, 2024
Recalling firm Graceleigh, Inc. dba Sammy's Milk
Units affected 2,487 units of 0.64oz Stick Paks
Distribution U.S. Distribution to the following states: AL, AK, AZ, AK, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, WY. All sales direct to …

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

Scale of Impact

2,487 units of 0.64oz Stick Paks 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?
Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak. Recalled by Graceleigh, Inc. dba Sammy's Milk. Units affected: 2,487 units of 0.64oz Stick Paks.
Why was this product recalled?
FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.
Which agency issued this recall?
This recall was issued by the FDA Food on May 29, 2024. Severity: Critical. Recall number: F-1248-2024.
Where was the recalled product distributed?
Distribution: U.S. Distribution to the following states: AL, AK, AZ, AK, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, WY. All sales direct to consumer..
How do I check if my product is affected by a recall?
Check the product description and recall number (F-1248-2024) 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).