Class IITerminated in FDA datasetRecall initiated Jun 30, 2020

Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from settling…

Recalling firm: Sundial Herbal Products

Why it was recalled

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Oct 26, 2022.

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ProductJamaican 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 antidote***Always have Sundial Bissy and Sundial Ethiopian mitmita (Cayenne pepper) for all medical emergencies***"

FDA code information

Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

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Full FDA record and distribution details

Original product description

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 antidote***Always have Sundial Bissy and Sundial Ethiopian mitmita (Cayenne pepper) for all medical emergencies***"

Original FDA recall reason

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Recall details

Recall number
F-1446-2020
Event ID
85882
FDA status
Terminated
Initiated
Jun 30, 2020
Reported
Sep 9, 2020
Classified
Sep 15, 2020
Terminated
Oct 26, 2022
Quantity
Unknown
Location
Bronx, NY, United States
Initiation type
FDA Mandated
Notification
Letter

Where it was distributed

NY

FDA source record · F-1446-2020

Data updated September 16, 2026. View official FDA data ↗

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