Sundial Blue Vervain Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Blue Vervain herbal products under a permanent injunction because the products are misbranded and deemed unapproved drugs.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and is required by an Order of Permanent Injunction, indicating a significant regulatory violation involving unapproved drugs.
Plain-English summary
Sundial Herbal Products is recalling Sundial Traditional Organic Herbs Blue Vervain, 1oz. The products are packaged in clear plastic zip-top bags and were distributed in New York. The recall is required by an Order of Permanent Injunction.
The FDA determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The source text does not specify the exact nature of the labeling claims or the specific health risks associated with the unapproved drug status.
Consumers who purchased these products should stop using them. The source text does not provide specific instructions for disposal or refund procedures.
The recalled product
- Product
- "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLUE VERVAIN***1oz.***USES:FEMALE PROBLEMS, WORMS & PARASITES***"; packaged in clear plastic zip-top bags
- Manufacturer
- Sundial Herbal Products
- Category
- Drug — 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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