Sundial Herbal Worms and Parasites Formula Recalled as Unapproved Drug
Sundial Herbal Products is recalling its Traditional Herbal Formula for Worms & Parasites because the product is misbranded and deemed an unapproved drug.
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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is primarily regulatory (misbranding/unapproved drug status) rather than a specific acute physical danger like a pathogen or structural defect.
Plain-English summary
Sundial Herbal Products is recalling its "SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" product, which is packaged in boxes. The recall is required by an Order of Permanent Injunction.
The FDA has determined that the products are misbranded and deemed unapproved drugs based on their labeling claims. The affected products were manufactured, processed, packed, held, and/or distributed during the time period beginning January 1, 2014, through May 27, 2020.
The distribution pattern for this recall is 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
- "SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes
- 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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