Sundial Traditional Herbal Formula Heart Recalled for Misbranding
Sundial Herbal Products is recalling its Traditional Herbal Formula Heart product because it is misbranded and deemed an unapproved drug.
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 2/5 (Moderate).
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 corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Sundial Herbal Products is recalling its "SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" 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 between January 1, 2014, and May 27, 2020.
The recall is limited to New York. Consumers who possess this product should stop using it and follow the instructions provided by the recalling firm or the FDA.
The recalled product
- Product
- "SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" 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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