Recall record at a glance
| Official record | F-1248-2024 |
|---|---|
| Category | Food Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Graceleigh, Inc. dba Sammy's Milk |
| Report date | May 29, 2024 |
| Recall initiation date | Apr 18, 2024 |
| Quantity | 2,487 units of 0.64oz Stick Paks |
| Location | Newport Beach, CA, United States |
Official product description
Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
Why the product was 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.
Distribution information
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 to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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