H&NATURAL TEJOCOTE ROOT 90 PIECES, 3 MONTH SUPPLY, PURE AND NATURAL RAIZ DE TEJOCOTE…
HandNatural recalled this product and the FDA reported the enforcement action on 24 April 2024 as Class I. The recall was initiated by the firm. Product recalled due to the presence of yellow oleander and its components in the product.
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
H&NATURAL TEJOCOTE ROOT 90 PIECES, 3 MONTH SUPPLY, PURE AND NATURAL RAIZ DE TEJOCOTE SUPPLEMENT FOR WOMEN AND MEN.
Reason for recall
Product recalled due to the presence of yellow oleander and its components in the product.
Firm is 100% internet sales. Distribution is unknown at this time.
Initiated
9 February 2024
Reported by FDA
24 April 2024
Firm notified by
E-Mail
Product codes
No Lot code on label. Expiration date listed as 05/24 and 03/24.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 15 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 15 separate recalls, which almost every published figure does, overstates it by a factor of 15. 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 15 of them.
This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
The FDA published the enforcement report 2 months after the firm began the recall.
Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Behind every recall is a clause 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.
