What happened
Original notice title
Stew Leonard’s Holdings LLC MARCS-CMS 681214, November 18, 2024
From the archived source record
Based on inspectional findings and review of the product labels collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with Stew Leonard’s brand Florentine Cookies, your firm recalled the cookies. Your Florentine Cookies products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergens, peanuts and egg, as required by section 403(w)(1) of the Act. Your Florentine Cookies and Rainbow Cookies products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients, and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Your Rainbow Cookies product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the Nutrition Facts label (NFL) is not in accordance with 21 CFR 101.9. This letter is not intended to be an all-inclusive list of the violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, or injunction. Please notify FDA in writing within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 0299b74c19ad
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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