Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
Summary
The FDA issued a Class I for Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak by Graceleigh, Inc. dba Sammy's Milk. Reason: FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading informatio.
Details
Source
Food Recall
External ID
F-1248-2024
Action Date
2024-05-29
Status
Terminated
Category
food
Product Description
Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
Lot/Code Info: Lot Code SD348, Best by date of August of 2025
Quantity Affected: 2,487 units of 0.64oz Stick Paks
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-18
Company
Newport Beach, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 27 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Graceleigh, Inc. dba Sammy's Milk has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Graceleigh, Inc. dba Sammy's Milk) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Graceleigh, Inc. dba Sammy's Milk have FDA actions?
Graceleigh, Inc. dba Sammy's Milk has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1248-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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