Toasted Almond & 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. 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 Almond & Cherry Biscotti
- Reason for recall
- Undeclared Red 40
- Recalling firm
- Gina Marie Bakery LLC
- Firm location
- Waterbury, Connecticut, United States
- Classification
- Class III
- Status
- Ongoing
- Recall number
- H-0007-2026
- 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: 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.
- Nuts and seeds carry both hazards at once: they are a major allergen in their own right, and as a low-moisture food they hold Salmonella for months without supporting its growth, which is why a nut butter recall can trace to a lot pressed a year earlier.
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.
Filed under nuts and seeds. A product can sit in more than one.
Other nuts and seeds recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
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 | Toasted Cherry Biscotti | Gina Marie Bakery LLC | Contains undeclared Red 40 | Class III |
| 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 | 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 accessRecall 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.