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Sundial Herbal Products
FDA recall F-1446-2020 · Class II · reported 2020-09-09 · Terminated
- Product
- 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***"
- Reason
- Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- Quantity
- Unknown
- Distribution
- NY
- Firm location
- NY, United States
- Initiated
- FDA Mandated
- First notice
- Letter
- Recall started
- 2020-06-30
- Terminated
- 2022-10-26
- Code info
- Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.