Sundial Herbal Products Recalls Ghanian Black Spice for Unapproved Drug Claims
Sundial Herbal Products is recalling Ghanian Black Spice because the product is misbranded and deemed an unapproved drug due to labeling claims.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves misbranding and unapproved drug claims, which aligns with the rubric for moderate severity involving labeling errors or regulatory violations without reported injuries.
Plain-English summary
Sundial Herbal Products is recalling Ghanian Black Spice under a permanent injunction. The product is being recalled because it is misbranded and deemed an unapproved drug based on its labeling claims.
The recall covers products manufactured, processed, packed, held, and/or distributed between January 1, 2014, and May 27, 2020. The distribution pattern is listed as New York (NY).
Consumers who possess this product should stop using it and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — Herbal Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product manufactured
- processed
- packed
- held
- and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 68 recalled by Sundial Herbal Products under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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