Class IITerminated · reported 2020-09-09

"SUNDIALTalibah's Tooth Powder"

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***Talibah's Tooth Powder***"
Reason for recall: Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Recalling firm: Sundial Herbal Products
Firm location: Bronx, New York, United States
Classification: Class II
Status: Terminated
Recall number: F-1506-2020
Quantity: Unknown
Distribution: NY
Initiated: 30 June 2020
Reported by FDA: 9 September 2020
Terminated: 26 October 2022
Firm notified by: Letter
Product codes: 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.
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

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.

Other records from Sundial Herbal Products

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 67 other records name this firm.

Reported	Product	Firm	Reason	Class
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE JOINTA1 oz.USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	SUNDIAL NIGERIAN MORINGA LEAF POWDER; "*Anti-inflammatory, builds Red Blood cells*" 4oz and 8oz jars	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSDOG BLOOD1 oz.USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE*"; packaged in clear plastic zip-top bag	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	Jamaican Bissy Powder; "*Bissy regulates the heart, removes and prevents water from settling around the heart, lessens the desire for drugs, cigarettes, alcohol by clearing the body and blood of poison viruses & toxins etc. Relieves fatigue gives stamina and endurance enabling one to do heavy work without getting tired. The tea also relieves depression, headaches, diarrhea, and dysentery. It's used as antibiotic and antidoteAlways have Sundial Bissy and Sundial Ethiopian mitmita (Cayenne pepper) for all medical emergencies**"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSWHITE SAGE2 oz.USES: EXCESS SWEATING, FEMALE HORMONE, SINUS INFECTION, INDIGESTION, KILLS BACTERIA*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSBREAD NUT1oz.USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE*"	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULAFlu-Allergies HayFever**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSQUASSIA WOOD2 oz.USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*Traditional Herbal ProductsTRADITIONAL ORGANIC HERBSCINNAMON1 oz.USES: STOMACH PAIN, MUCOUS CONGESTION, COLDS, NOSE BLEED, STIMULANT, FLAVORING*"; packaged in clear plastic zip-top bags	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II
2020-09-09	"SUNDIAL*TRADITIONAL HERBAL FORMULABLOOD PRESSURE**" packaged in boxes	Sundial Herbal Products	Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.	Class II

All 68 records for Sundial Herbal Products

All 2020 recalls · All FDA food recall data

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.

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.

"SUNDIAL***Talibah's Tooth Powder***"