"SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
Recalling firm: Sundial Herbal Products
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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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
"SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
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-1495-2020
- 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
Data updated September 16, 2026. View official FDA data ↗
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