Class IITerminated · reported 2023-05-17

Bourbon Truffle

Windy Hill Chocolate LLC recalled this product and the FDA reported the enforcement action on 17 May 2023 as Class II. The recall was initiated by the firm. Undeclared Allergens: Soy, Milk and Tree Nuts

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
Bourbon Truffle
Reason for recall
Undeclared Allergens: Soy, Milk and Tree Nuts
Firm location
Jacksonville, Florida, United States
Classification
Class II
Status
Terminated
Recall number
F-0843-2023
Quantity
192 cello packs/2 units each and 40 units/3 cookies per unit (Oreo) -total
Distribution
Domestic consignee only.
Initiated
22 March 2023
Reported by FDA
17 May 2023
Terminated
31 July 2023
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Batch #0706220077

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 is one of 17 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 17 separate recalls, which almost every published figure does, overstates it by a factor of 17. 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 17 of them.
  • The recall ran for 4 months, from 22 March 2023 to termination on 31 July 2023. 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 8 weeks after the firm began the recall.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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.

The allergens named in this record: milk, soy, tree nuts.

Other records from Windy Hill Chocolate LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 16 other records name this firm.

ReportedProductFirmReasonClass
2023-05-17Coffee BonbonWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17PistachioWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Mango BonbonWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Key Lime BonbonWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Ginger LimeWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Sunrise MimosaWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Pear AlmondWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Peanut Butter PralineWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Chocolate Covered OreosWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II
2023-05-17Midnight BonbonWindy Hill Chocolate LLCUndeclared Allergens: Soy, Milk and Tree NutsClass II

All 17 records for Windy Hill Chocolate LLC

All 2023 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.