Food recall: Italian Mixed Vanilla Cookies
FDA enforcement event 97587 is a food recall by Gina Marie Bakery LLC of Waterbury, CT, initiated 10 Sep 2025 and classified Class II, with 7 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 54% of the 569 food enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Gina Marie Bakery LLC.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gina Marie Bakery LLC, Waterbury, CT.
Reason for recall
"Undeclared Red 40"
Distribution
"Firm notified FDA of recall initiated by state of CT on 09/10/25. A copy of CT press release was requested for posting by FDA. Firm notified customers on 09/11/25."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| H-0003-2026 | Italian Mixed Vanilla Cookies | 172 cases (20 containers per case) [total] | Class II | Ongoing | 8 Oct 2025 |
| H-0004-2026 | Italian Sesame Cookies | 172 cases (20 containers per case) [total] | Class II | Ongoing | 8 Oct 2025 |
| H-0005-2026 | Vanilla Chocolate Dipped Cookies | 172 cases (20 containers per case) [total] | Class III | Ongoing | 8 Oct 2025 |
| H-0006-2026 | Vanilla with Apricot Jam Cookies | 172 cases (20 containers per case) [total] | Class II | Ongoing | 8 Oct 2025 |
| H-0007-2026 | Toasted Almond & Cherry Biscotti | 172 cases (20 containers per case) [total] | Class III | Ongoing | 8 Oct 2025 |
| H-0008-2026 | Vanilla Cookies with Raspberry Peach Jam | 172 cases (20 containers per case) [total] | Class II | Ongoing | 8 Oct 2025 |
| H-0009-2026 | Toasted Cherry Biscotti | 172 cases (20 containers per case) [total] | Class III | Ongoing | 8 Oct 2025 |
Context
Questions and answers
Why was this food recalled?
FDA's record gives the reason for recall as: "Undeclared Red 40"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Firm notified FDA of recall initiated by state of CT on 09/10/25. A copy of CT press release was requested for posting by FDA. Firm notified customers on 09/11/25."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.