Class IIITerminated · reported 2026-06-17

ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL.

Refresqueria Estrella Inc. recalled this product and the FDA reported the enforcement action on 17 June 2026 as Class III. The recall was initiated by the firm. Undeclared FD&C 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
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
Reason for recall
Undeclared FD&C Red 40
Recalling firm
Refresqueria Estrella Inc.
Firm location
Bayamon, Puerto Rico, United States
Classification
Class III
Status
Terminated
Recall number
H-0913-2026
Quantity
Total: 2,111---14 oz-1,291, 64 oz-114 and 120 oz -706
Distribution
Puerto Rico distribution only.
Initiated
19 May 2026
Reported by FDA
17 June 2026
Terminated
18 August 2026
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
May Production Lot Code:12426, 13126, 13426. 4/8/2026 Expiration Date: 4/8/2026, 5/8/2026, 6/8/2026, 11/8/2026, 11/8/2026, 14-08-2026, 14-08-2026 April Production Lot Code: 9226, 9626, 9826, 9926, 10326, 10626, 11026, 11126, 11326, 11826, 11926, 12026 Expiration Date:2/7/2026, 6/7/2026, 8/7/2026, 9/7/2026, 13-07-2026, 16-07-2026, 16-07-2026, 20-07-2026, 21-07-2026, 22-07-2026, 23-07-2026, 23-07-2026, 28-07-2026, 29-07-2026 30-07-2026 March Production Lot Code:6126, 6426, 7026, 9926, 8326, 8226, 8626, 9026 Expiration Date: 2/6/2026, 5/6/2026, 11/6/2026, 20-06-2026, 23-06-2026, 24-06-2026, 27-06-2026, 30-06-2026

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 19 May 2026 to termination on 18 August 2026. 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 FDA published the enforcement report 4 weeks after the firm began the recall.
  • Recalls of a beverage or juice run a median of 6 months, so this one was shorter than usual for its category. Juice is the other food with its own HACCP regulation in the United States, 21 CFR part 120, which requires a treatment achieving a 5-log reduction of the pertinent pathogen, and unpasteurised juice recalls are almost always a failure of that step or an exemption misapplied.

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

Other beverages and juice 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
2026-09-02ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125846.Lidl US TRADINGThe firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).Class II
2026-08-26Protein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno, NV 89523. No UPC Not for individual retail saleNutrient Foods, LLCSoy not declared in the contains statement.Class II
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
2026-07-08FIRST STREET Dark Chocolate Raisins Net Wt. 9 oz. (255g) UPC 797565011830 INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, MILK FAT, SOY LECITHIN - AN EMULSIFIER, NATURAL VANILLA FLAVOR), RAISINS, TAPIOCA DEXTRIN, CONFECTIONERS GLAZE. CONTAINS: MILK, SOY PACKED IN A FAICLITY THAT HANDLES PEANUTS, TREE NUTS, WHEAT, SOY, EGG, SESAME, AND MILK PRODUCTS.Western Mixers Produce & Nuts, Inc.Undeclared peanuts.Class I
2026-06-03Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottleWawa Beverage CompanyUndeclared Milk Allergen,Class I
2026-06-03Wawa Diet Lemonade Pint (16oz), Plastic bottleWawa Beverage CompanyUndeclared Milk Allergen,Class I
2026-06-03Wawa Iced Tea Lemon 16 oz Pint, Plastic bottleWawa Beverage CompanyUndeclared Milk Allergen,Class I
2026-05-20Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar, corn syrup, butter, vanilla, baking soda, sea salt, white chocolate (sugar, palm kernel fat, skimmed milk powder [12%], emulsifier [lecithins], natural vanilla flavoring), dark chocolate (sugar, palm kernel fat, fat reduced cocoa powder [20%], emulsifiers [lecithins], natural vanilla flavoring), pretzels (flour, water, salt, malt, dextrose, canola oil, yeast, soda), tofee bits (sugar, butter, almonds), coarse sea salt.; CONTAINS: MILK, TREE NUTS (ALMONDS), WHEAT; Produced in a facility that is shared with gluten, nuts, dairy, and soy.; Manufactured by: Prospector Popcord, LLC, Ridgefield, CT 06877; UPC: 850073852125Prospector Popcorn, LLCProducts contain undeclared soy, specifically soy lecithin.Class II

All 2026 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.