Class IIITerminated · reported 2020-03-04

Paleonola Grain Free Granola; The Original; packaged in 10oz stand-up pouches; UPC…

Paleonola Llc recalled this product and the FDA reported the enforcement action on 4 March 2020 as Class III. The recall was initiated by the firm. Potentially contaminated with an unapproved herbicide, haloxyfop.

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
Paleonola Grain Free Granola; The Original; packaged in 10oz stand-up pouches; UPC 013964497144
UPC
013964497144
Reason for recall
Potentially contaminated with an unapproved herbicide, haloxyfop.
Recalling firm
Paleonola Llc
Firm location
Pawtucket, Rhode Island, United States
Classification
Class III
Status
Terminated
Recall number
F-0788-2020
Quantity
7,388 Cases Total
Distribution
NJ, NH, MA, FL, RI
Initiated
18 February 2020
Reported by FDA
4 March 2020
Terminated
4 May 2020
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Best By dates: 091720, 092420, 092920, 093020, 100520, 100720, 100820, 101220, 101620

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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. 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 6 of them.
  • The recall ran for 2 months, from 18 February 2020 to termination on 4 May 2020. 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 5 states, and the FDA published the enforcement report 2 weeks after the firm began the recall.
  • Recalls of a snack or confectionery product run a median of 7 months, so this one was shorter than usual for its category. Snacks and confectionery recall for allergens more than for anything else, because a chocolate or a coated snack passes through shared equipment carrying milk, soy and nuts, and the label is the only control between them and the consumer.

Named in the distribution pattern: New Jersey, New Hampshire, Massachusetts, Florida, Rhode Island. 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

Chemical contamination

A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.

A preventive controls plan covers chemical contamination 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 117.35(b)
Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
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.
21 CFR 117.130(b)(1)(ii)
Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.

Unapproved ingredients

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

A preventive controls plan covers an unapproved ingredient 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 111
Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
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 snacks and confectionery and grains, flour and pasta. A product can sit in more than one.

Other snacks and confectionery 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
2026-01-071) Paw Patrol Heart-Shaped Gummy Candies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643846, Distributed by Bendon, Inc. 2) Mickey Mouse Heart-Shaped Gummies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643853, Distributed by Bendon, Inc. 3) Stitch Heart-Shaped Gummies, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643860, Distributed by Bendon, Inc. 4) SpongeBob Squarepants Heart-Shaped Gummy Candy, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219644225, Distributed by Bendon, Inc. 5) Toy Story Multipack Size Gummies, Mixed Fruit, Net Wt. 6.35 oz (180g), packaged in a plastic bag containing 20 mini size packs (0.4 oz each), UPC 805219643914, Distributed by Bendon, Inc.Bendon PublishingUnapproved color additive - chlorophyllin copper complexClass III
2024-10-09Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up pouch bags with inner plastic liner with SKU PC-GRUCCP-1LB. Product of Guatemala. Distributed Soul Lift Cacao of Portland, Oregon. The product is 100% pure cacao (chocolate) which is not ready for consumption. In most cases it is prepared into a chocolate drink with hot water and a blender.Inner Waymark LLCElevated lead level 0.671 ppm in cacao (chocolate)Class II
2024-08-07Diamond Shruumz Chocolate Bars Dark Chocolate UPC 755003858829Prophet Premium Blends, LLCToxic levels of muscimolClass I
2024-08-07Diamond Shruumz Infused Cones Double Chocolate Chip UPC 810133320001Prophet Premium Blends, LLCToxic levels of muscimolClass I
2024-08-07Diamond Shruumz Chocolate Bars Birthday Cake UPC 75503858867Prophet Premium Blends, LLCToxic levels of muscimolClass I
2024-08-07Diamond Shruumz Chocolate Bars Fruity Cereal UPC 755003858799Prophet Premium Blends, LLCToxic levels of muscimolClass I
2024-08-07Diamond Shruumz Chocolate Bars Cookies & Cream UPC 755003858782Prophet Premium Blends, LLCToxic levels of muscimolClass I
2024-08-07Diamond Shruumz Chocolate Bars Cookie Butter UPC 755003858751Prophet Premium Blends, LLCToxic levels of muscimolClass I

Other records from Paleonola Llc

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.

ReportedProductFirmReasonClass
2020-03-04Paleonola Grain Free Granola; Pumpkin Pie; packaged in 10oz stand-up pouches; UPC 013964497137Paleonola LlcPotentially contaminated with an unapproved herbicide, haloxyfop.Class III
2020-03-04Paleonola Grain Free Granola; Maple Pancake; packaged in 10oz stand-up pouches; UPC 013964497120Paleonola LlcPotentially contaminated with an unapproved herbicide, haloxyfop.Class III
2020-03-04Paleonola Grain Free Granola; Chocolate Fix; packaged in 10oz stand-up pouches; UPC 013964497113Paleonola LlcPotentially contaminated with an unapproved herbicide, haloxyfop.Class III
2020-03-04Paleonola Grain Free Granola; Pina Colada; packaged in 10oz stand-up pouches; UPC 091037367808Paleonola LlcPotentially contaminated with an unapproved herbicide, haloxyfop.Class III
2020-03-04Paleonola Grain Free Granola; Apple Pie; packaged in 10oz stand-up pouches; UPC 013964497106Paleonola LlcPotentially contaminated with an unapproved herbicide, haloxyfop.Class III

All 6 records for Paleonola Llc

All 2020 recalls · All FDA food recall data

21 CFR 117.35(b) 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.