Class IIITerminated · reported 2018-12-19

Gatorade, Melon, 20.3 FL OZ, Cont. Neto (600 mL)

The Gatorade Puerto Rico Co recalled this product and the FDA reported the enforcement action on 19 December 2018 as Class III. The recall was initiated by the firm. Product is contaminated with mold.

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
Gatorade, Melon, 20.3 FL OZ, Cont. Neto (600 mL)
Reason for recall
Product is contaminated with mold.
Firm location
Miami, Florida, United States
Classification
Class III
Status
Terminated
Recall number
F-0708-2019
Quantity
(Quantities distributed are within Combo Multipack Item #8)
Distribution
Domestic Consignees only. No foreign nor government consignees.
Initiated
9 November 2018
Reported by FDA
19 December 2018
Terminated
3 September 2019
Firm notified by
Letter
Product codes
24/600 mL: lot 002259, Exp. Date 7/23/2019

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 8 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 8 separate recalls, which almost every published figure does, overstates it by a factor of 8. 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 8 of them.
  • The recall ran for 10 months, from 9 November 2018 to termination on 3 September 2019. 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 6 weeks after the firm began the recall.
  • Recalls of fresh produce run a median of 7 months, so this one was longer 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.

What this recall was for

Spoilage and mould

A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.

A preventive controls plan covers spoilage 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 117.93
Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
21 CFR 117.80(b)(3)
Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.

Filed under fresh produce. 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
2025-10-22Dole Apple Juice (primary package), 15.2 Fl oz., PET, 12 bottles per case, Refrigerate after openingTROPICANA BRANDS GROUPA manufacturing process deviation occurred which may cause spoilage or microbial contamination and affect shelf stability.Class II
2025-10-15Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (60 ML)M.O.M Enterprises, LLC.Potential yeast contamination.Class II
2025-09-17Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (60 ML)M.O.M Enterprises, LLC.Potential for spoilage due to yeast contamination.Class II
2025-06-25Pizza Shoppe The "Pink Stuff" World-Famous Creamy Garlic Salad Dressing, net wt. 12oz, UPC 896537002019 packaged in clear plastic bottle with twist lid. Bottles are packed 6/case.La Fontanella Food Products LLCPotential for product spoilage (increased level of lactic acid detected in retain samples).Class II
2024-09-11Item 41303.82013, Reser's Essential Everyday Original Potato Salad, refrigerated product, net wt. 16oz. There are 6 packs per case.Reser's Fine Foods, Inc.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.Class II
2024-09-11Item 71117.15207, Reser's Raspberry Parfait Desserts, refrigerated product, net wt. 8lb. There are 2 packs per case.Reser's Fine Foods, Inc.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.Class II
2024-09-11Item 71117.10923, Reser's Smokehouse Potato Salad, refrigerated product, net wt. 5lbs. There are 2 packs per case.Reser's Fine Foods, Inc.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.Class II
2024-09-11Item 71117.18531, Stonemill Kitchens Green Goddess Pasta Salad, refrigerated product, net wt. 5lb. There are 2 packs per case.Reser's Fine Foods, Inc.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.Class II

Other records from The Gatorade Puerto Rico Co

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 7 other records name this firm.

ReportedProductFirmReasonClass
2018-12-19Gatorade, Lemon Lime, 20.3 FL OZ, Cont. Neto (600 mL)The Gatorade Puerto Rico CoProduct is contaminated with mold.Class III
2018-12-19Gatorade, Orange, 20.3 FL OZ, Cont. Neto (600 mL)The Gatorade Puerto Rico CoProduct is contaminated with mold.Class III
2018-12-19Gatorade, Grape, 20.3 FL OZ, Cont. Neto (600 mL)The Gatorade Puerto Rico CoProduct is contaminated with mold.Class III
2018-12-19Gatorade, Frost Glacier Freeze, Cont. Neto (600 mL)The Gatorade Puerto Rico CoProduct is contaminated with mold.Class III
2018-12-19Gatorade, Cool Blue, 20.3 FL OZ, Cont. Neto (600 mL)The Gatorade Puerto Rico CoProduct is contaminated with mold.Class III
2018-12-19Gatorade, Fruit Punch, 20.3 FL OZ, Cont. Neto (600 mL)The Gatorade Puerto Rico CoProduct is contaminated with mold.Class III
2018-12-19Gatorade Combo (Multipack) 24/600 mLThe Gatorade Puerto Rico CoProduct is contaminated with mold.Class III

All 8 records for The Gatorade Puerto Rico Co

All 2018 recalls · All FDA food recall data

21 CFR 117.93 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.