Class IIITerminated · reported 2017-12-20

Premio Strawberry Pralinati, Strawberry with Cocoa, 3.53oz, 10 units per case, packed in…

Gourmet International Inc. recalled this product and the FDA reported the enforcement action on 20 December 2017 as Class III. The recall was initiated by the firm. Gourmet International Inc. is initiating a voluntary recall of cookie products due to undeclared colors.

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
Premio Strawberry Pralinati, Strawberry with Cocoa, 3.53oz, 10 units per case, packed in Paper Cartons
Reason for recall
Gourmet International Inc. is initiating a voluntary recall of cookie products due to undeclared colors.
Firm location
Grand Rapids, Michigan, United States
Classification
Class III
Status
Terminated
Recall number
F-0486-2018
Quantity
24,179 cases 241,790 units
Distribution
Domestic: Domestic only, no VA/DOD KY, TX, WI, Washington DC, PA, VA, MO, FL, OH, SC, AL, CA, IN,
Initiated
2 November 2017
Reported by FDA
20 December 2017
Terminated
31 January 2018
Firm notified by
E-Mail
Product codes
UPC- 8-16240-02015-5 all lots, all dates, all packages

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
  • The recall ran for 3 months, from 2 November 2017 to termination on 31 January 2018. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
  • The distribution pattern names 11 states, and the FDA published the enforcement report 7 weeks after the firm began the recall.
  • Recalls of fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.

Named in the distribution pattern: Texas, Wisconsin, Pennsylvania, Virginia, Missouri, Florida, Ohio, South Carolina, Alabama, California, Indiana. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

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 fresh produce and beverages and juice. A product can sit in more than one.

Other fresh produce 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.

ReportedProductFirmReasonClass
2026-09-02Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Peppers, Garlic, Onions, Water, Distilled 5% White Vinegar, Spices***Manufactured and Packed By Africando Foods, LLC 1121S Gilbert Ct. Iowa City, IA 52240***"Africando Foods LLCLabeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient listUnclassified
2026-08-19Lyle Style Mild Bloody Mary Mix, 32oz. glass bottle. UPC code 7 84762 03730 3. The label declares "***Ingredients***Tomato Juice ***lemon***Worcestershire sauce (vinegar, molasses, water, corn sweeteners, caramel coloring, anchovies, natural flavorings)***Made in the Columbia River Gorge - Lyle, Washington***"Lyle StyleUndeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.Class II
2026-08-19Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.SHEANDRO LLCLabel declares cream and cheese, but Milk is not declaredClass II
2026-08-12Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net Wt. 8.2 oz (232g) UPC 1 00001 00029 7 and Sprig & Sprout Spicy Breakfast Burrito IN A SPICY TORTILLA NET WEIGHT 8.3oz (234g) Contains: Egg, Milk, Wheat. MG Foods Charlotte, NC 28272M.G. Foods, Inc.Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.Class I
2026-07-22Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494D'Dioses Fruit Pops, Inc.May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Class I
2026-07-15Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,Wise Foods IncThe product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.Class II
2026-07-15Johnny's Salad and Pasta Elegance 5.5 oz (UPC: 0-70381-10014-9) " Johnny's Salad and Pasta Elegance 2.75 oz (UPC: 0-70381-10013-2)Adams Extract & Spice LLCUndeclared Sesame allergenClass II
2026-06-17Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852843Galaxy RG CorpUndeclared colors (Yellow #5, Yellow #6, and/or Red #40).Class II

Other records from Gourmet International Inc.

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

ReportedProductFirmReasonClass
2018-08-29SPARKLING POMEGRANETE JUICE DRNK, 6/34 oz., glass bottlesGourmet International Inc.Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.Class II
2018-08-29SPARKLING MANDARIN JUICE DRINK, 6/34 oz., glass bottlesGourmet International Inc.Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.Class II
2018-08-29SPARKLING GRAPEFRUIT JUICE DRINK, 6/34 oz., glass bottlesGourmet International Inc.Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.Class II
2018-08-29SPARKLING SOUR CHERRY JUICE DRINK, 6/34 oz., glass bottlesGourmet International Inc.Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.Class II
2018-08-29SPARKLING LEMON JUICE DRINK , 6 /34 oz., glass bottlesGourmet International Inc.Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.Class II
2018-08-29SPARKLING LIME JUICE DRINK, 6/34 oz, glass bottlesGourmet International Inc.Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.Class II

All 7 records for Gourmet International Inc.

All 2017 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.