"SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
Sundial Herbal Products recalled this product and the FDA reported the enforcement action on 9 September 2020 as Class II. The recall was mandated. Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
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
"SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
Reason for recall
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
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.
This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall are set out in 21 CFR 7.45.
This is one of 68 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 68 separate recalls, which almost every published figure does, overstates it by a factor of 68. 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 68 of them.
The recall ran for 2.3 years, from 30 June 2020 to termination on 26 October 2022. 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 1 state, and the FDA published the enforcement report 2 months after the firm began the recall.
Recalls of a beverage or juice run a median of 6 months, so this one was longer 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.
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.
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.
21 CFR 111 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.
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.
