Summary
The FDA issued a Class II for Italian Mixed Vanilla Cookies by Gina Marie Bakery LLC. Reason: Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1.
Details
Source
Food Recall
External ID
H-0003-2026
Action Date
2025-10-08
Status
Ongoing
Category
food
Product Description
Italian Mixed Vanilla Cookies
Lot/Code Info: UPC: 757808003169
Quantity Affected: 172 cases (20 containers per case) [total]
Reason for Recall
Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-10
Company
Waterbury, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Gina Marie Bakery LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gina Marie Bakery LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gina Marie Bakery LLC have FDA actions?
Gina Marie Bakery LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0003-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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