Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt.
Inner Waymark LLC recalled this product and the FDA reported the enforcement action on 9 October 2024 as Class II. The recall was initiated by the firm. Elevated lead level 0.671 ppm in cacao (chocolate)
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
- Heart 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.
- Reason for recall
- Elevated lead level 0.671 ppm in cacao (chocolate)
- Recalling firm
- Inner Waymark LLC
- Firm location
- Portland, Oregon, United States
- Classification
- Class II
- Status
- Ongoing
- Recall number
- F-0004-2025
- Quantity
- 60/1lb. bags
- Distribution
- Distributed to CA, FL, IL, KY, MD, ME, MI, MO, MT, NH, NY, OR, TX, UT, and WI.
- Initiated
- 21 August 2024
- Reported by FDA
- 9 October 2024
- Firm notified by
- Product codes
- Lot #506 with "best by" date June 18, 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 II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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.
- This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
- The distribution pattern names 14 states, and the FDA published the enforcement report 7 weeks after the firm began the recall.
- 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: Florida, Illinois, Kentucky, Maryland, Maine, Michigan, Missouri, Montana, New Hampshire, New York, Oregon, Texas, Utah, Wisconsin. 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.
Filed under snacks and confectionery and beverages and juice. 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.
All 2024 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 accessRecall 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.