Sundial Purple Sage Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Purple Sage herbal products under a permanent injunction because the labeling makes unapproved drug 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 and regulatory violations without reported injuries.
Plain-English summary
Sundial Herbal Products is recalling its "Traditional Organic Herbs" Purple Sage product, packaged in clear plastic zip-top bags. The recall is required by an Order of Permanent Injunction.
The FDA determined that the products are misbranded and deemed unapproved drugs based on the labeling claims. The product labeling lists uses including depression, insect bites, insomnia, and relieving congestion.
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 should stop using the product and follow instructions from the recalling firm or the FDA.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PURPLE SAGE***1 oz.***USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION***"; packaged in clear plastic zip-top bags
- Manufacturer
- Sundial Herbal Products
- Category
- Food — Herbal Supplements
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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