Class IIIOngoing · reported 2025-10-08

Toasted Cherry Biscotti

Gina Marie Bakery LLC recalled this product and the FDA reported the enforcement action on 8 October 2025 as Class III. The recall was initiated by the firm. Contains undeclared Red 40

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: Toasted Cherry Biscotti
Reason for recall: Contains undeclared Red 40
Recalling firm: Gina Marie Bakery LLC
Firm location: Waterbury, Connecticut, United States
Classification: Class III
Status: Ongoing
Recall number: H-0009-2026
Quantity: 172 cases (20 containers per case) [total]
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.
Initiated: 10 September 2025
Reported by FDA: 8 October 2025
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: UPC Code 757808003282

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This is one of 7 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 7 separate recalls, which almost every published figure does, overstates it by a factor of 7. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 7 of them.
This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
The FDA published the enforcement report 4 weeks after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

What this recall was for

Undeclared allergens

An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.

A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 117.135(c)(2): Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4: Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G: Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

Other records from Gina Marie Bakery LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.

Reported	Product	Firm	Reason	Class
2025-10-08	Vanilla Cookies with Raspberry Peach Jam	Gina Marie Bakery LLC	Undeclared Red 3 and Blue 1	Class II
2025-10-08	Italian Sesame Cookies	Gina Marie Bakery LLC	Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6	Class II
2025-10-08	Vanilla with Apricot Jam Cookies	Gina Marie Bakery LLC	Undeclared Red 40 and Yellow 6	Class II
2025-10-08	Vanilla Chocolate Dipped Cookies	Gina Marie Bakery LLC	Undeclared Red 40	Class III
2025-10-08	Toasted Almond & Cherry Biscotti	Gina Marie Bakery LLC	Undeclared Red 40	Class III
2025-10-08	Italian Mixed Vanilla Cookies	Gina Marie Bakery LLC	Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1	Class II

All 7 records for Gina Marie Bakery LLC

All 2025 recalls · All FDA food recall data

21 CFR 117.135(c)(2) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.